13 Policy Lead jobs in Ireland

Regulatory Affairs Manager

Cork, Munster Stryker

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Job Description

**Regulatory Affairs Manager- candidate can come from Quality or Regulatory background.**
**This is a permanent role with full Stryker benefits- bonus, pension and healthcare for employee and their family.**
**Key Areas of Responsibility:**
+ Assesses links between global, societal and economic trends; stakeholder concerns and regulatory issues and requirements; and the implications for regulatory strategy
+ Develops and updates global, regional and multi-country regulatory strategy, and aligns regulatory strategies to organizational strategies
+ Provides guidance to integrate regulatory considerations into global product entry and exit strategy
+ Identifies regulatory pathways for initial product designs and provides input to internal stakeholders
+ Analyzes the adequacy of proposed regulatory pathways and strategy for initial product designs and recommends changes or refinements based on initial regulatory outcomes
+ Assesses all requirements and potential obstacles for market access and distribution (federal, provincial/territorial/state, reimbursement, purchasing groups, etc.) and develops solutions to address anticipated obstacles
+ Critically assesses the impact of changing regulations on preapproval and post approval strategies and approaches based on changing regulations
+ Provides in-depth understanding and ability to incorporate regulatory strategies to expedite development for products intended for serious or life-threatening medical conditions or that address unmet medical needs (e.g. orphan, conditional approval, breakthrough therapy)
+ Negotiates with regulatory authorities on complex issues throughout the product lifecycle
+ Establishes working relationships and interfaces with multiple government and non-government organizations having an impact on market access and distribution
+ Identifies the need for and manages the development and execution of new regulatory procedures and standard operating procedures
+ Develops and manages programs that train stakeholders on current and new regulatory requirements to ensure organization-wide compliance
+ Provides strategic input and technical guidance on global regulatory requirements to product development terms
+ Evaluates risks of product and clinical safety issues during clinical phases and recommends regulatory solutions
+ Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans for changes that do not require submissions
+ Reviews and assesses proposals to regulatory authorities on regulatory paths and clinical plans
+ Monitors implementation of regulatory strategies relative to product and clinical safety issues identified during clinical phases
+ Provides knowledge and critical analysis of preapproval inspections, GCP inspections and clinical investigator relationships
+ Provides regulatory guidance on strategy for proposed product claims/labeling
+ Ensures clinical and nonclinical data are consistent with the regulatory requirements and support the proposed product claims
+ Ensures policies and procedures are in place for appropriate internal review and approval of regulatory submissions
+ Leads key negotiations and interactions with regulatory authorities during all stages of the development and review process
+ Prepares cross-functional teams for interactions with regulatory authorities including panel/advisory committees
**Education / Work Experience:**
+ BS in a science, engineering or related Advanced degree preferred
+ Minimum of 8 years experience
+ People Management experience required
#IJ
#INDEMEA
This role will be posted for a minimum of 3 days.
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.
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Regulatory Affairs Manager

Dunboyne, Leinster Amicus Recruitment

Posted 2 days ago

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Job Description

Group Regulatory Affairs Manager Pharmaceuticals (Hybrid) Location: Offices based near Dunboyne, Co. Meath, Ireland Our client is a thriving Irish pharmaceutical group experiencing significant growth. Through consistent organic expansion and strategic acquisitions they have built a strong portfolio of market-leading OTC and Prescription medicines. Their products are marketed across numerous EU countries, Australia, and New Zealand. Due to their continued expansion, they are seeking a highly motivated and experienced Group Regulatory Affairs Manager to join their growing team. This is a fantastic opportunity to make a tangible impact within a dynamic, family-run business that prioritises performance and offers excellent career progression. What You'll Do: As the Group Regulatory Affairs Manager, you'll play a crucial role in ensuring the clients diverse product portfolio complies with global regulatory frameworks. This is a hands-on management position where you'll be expected to get stuck in and drive results. Your key responsibilities will include: Developing and implementing robust regulatory strategies to support product development and lifecycle management, particularly for our expanding portfolio acquired through acquisitions. Leading and mentoring a team of Regulatory Affairs Officers, fostering a collaborative and high-performing environment. Efficiently integrating all new portfolio acquisitions across multiple international markets. Spearheading projects to identify and resolve gaps in regulatory dossiers. Leading high-level meetings with Regulatory Authorities. Driving the regulatory aspects of internationalizing products and pursuing reclassification when appropriate. Proactively monitoring and interpreting global regulatory trends and changes, ensuring the company is always ahead of the curve. Collaborating cross-functionally with our Quality and Commercial/Marketing teams to achieve overarching company objectives. What You'll Bring: Our client is looking for a resilient and adaptable individual with a strong sense of ownership and a proven track record in regulatory affairs. Essential Experience & Knowledge: 8-10 years of progressive experience in Regulatory Affairs within the pharmaceutical industry (human health). Strong knowledge of global regulatory frameworks, including MRP, DCP, and CP procedures. Demonstrable experience with pharmaceutical products, specifically OTC and/or prescription medicines, with a focus on preparing and submitting dossiers for multiple EU countries. A proactive, "roll up your sleeves" attitude with a strong drive to see tasks through to conclusion. Exceptional attention to detail and outstanding organisational skills. Ability to work autonomously, take initiative, and assume responsibility for your actions. Highly Desirable: Knowledge of medical device regulations. Experience with cosmetics regulations. Whats On Offer: Competitive Salary: A highly competitive salary, negotiable based on your experience. For a manager-level role like this. Performance-Based Bonuses: Your hard work and contributions will be recognized and rewarded through performance-based bonuses. Hybrid Working: Our client embraces a hybrid working model to offer flexibility while fostering team collaboration. You'll be required in their offices near Dunboyne, Co. Meath three days a week.They offerflexible start and finish times around their contracted 9-5 hours to help avoid peak traffic. Career Progression: With a turnover of €250 million and ambitious growth plans, the opportunities for professional development and career advancement within the company are significant. If you're a seasoned Regulatory Affairs professional looking for a challenging yet rewarding role within a rapidly expanding pharmaceutical group, we encourage you to apply! Benefits: Performance Bonus
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Regulatory Affairs Manager

Cork, Munster Stryker Ireland

Posted 2 days ago

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Job Description

Regulatory Affairs Manager- candidate can come from Quality or Regulatory background. This is a permanent role with full Stryker benefits- bonus, pension and healthcare for employee and their family. Key Areas of Responsibility: Assesses links between global, societal and economic trends; stakeholder concerns and regulatory issues and requirements; and the implications for regulatory strategy Develops and updates global, regional and multi-country regulatory strategy, and aligns regulatory strategies to organizational strategies Provides guidance to integrate regulatory considerations into global product entry and exit strategy Identifies regulatory pathways for initial product designs and provides input to internal stakeholders Analyzes the adequacy of proposed regulatory pathways and strategy for initial product designs and recommends changes or refinements based on initial regulatory outcomes Assesses all requirements and potential obstacles for market access and distribution (federal, provincial/territorial/state, reimbursement, purchasing groups, etc.) and develops solutions to address anticipated obstacles Critically assesses the impact of changing regulations on preapproval and post approval strategies and approaches based on changing regulations Provides in-depth understanding and ability to incorporate regulatory strategies to expedite development for products intended for serious or life-threatening medical conditions or that address unmet medical needs (e.g. orphan, conditional approval, breakthrough therapy) Negotiates with regulatory authorities on complex issues throughout the product lifecycle Establishes working relationships and interfaces with multiple government and non-government organizations having an impact on market access and distribution Identifies the need for and manages the development and execution of new regulatory procedures and standard operating procedures Develops and manages programs that train stakeholders on current and new regulatory requirements to ensure organization-wide compliance Provides strategic input and technical guidance on global regulatory requirements to product development terms Evaluates risks of product and clinical safety issues during clinical phases and recommends regulatory solutions Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans for changes that do not require submissions Reviews and assesses proposals to regulatory authorities on regulatory paths and clinical plans Monitors implementation of regulatory strategies relative to product and clinical safety issues identified during clinical phases Provides knowledge and critical analysis of preapproval inspections, GCP inspections and clinical investigator relationships Provides regulatory guidance on strategy for proposed product claims/labeling Ensures clinical and nonclinical data are consistent with the regulatory requirements and support the proposed product claims Ensures policies and procedures are in place for appropriate internal review and approval of regulatory submissions Leads key negotiations and interactions with regulatory authorities during all stages of the development and review process Prepares cross-functional teams for interactions with regulatory authorities including panel/advisory committees Education / Work Experience: BS in a science, engineering or related Advanced degree preferred Minimum of 8 years experience People Management experience required #IJ #INDEMEA To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process, click the Apply button below to Login/Register.
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Regulatory Affairs Manager

Galway, Connacht Life Science Recruitment Ltd

Posted 2 days ago

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Regulatory Affairs Manager Our client a fast-growing medical device company based in the West of Ireland, dedicated to transforming outcomes for patients are seeking a highly motivated Regulatory Affairs Manager to lead and oversee all regulatory compliance activities. This critical leadership role will define and execute regulatory strategies in support of both new product development and post-market activities. Role/Responsibilities Lead the regulatory strategy for new product introductions and support existing products through their full lifecycle. Manage regulatory submissions (e.g. 510(k), CE Mark) and global product registrations. Act as the primary contact for regulatory agencies, including authorities in the U.S. and Europe. Monitor and interpret evolving regulatory requirements and apply them to ensure company compliance. Partner with Quality Assurance to ensure post-market surveillance and vigilance activities meet applicable standards. Review and approve promotional and advertising materials from a regulatory perspective. Identify and allocate internal and external resources needed to maintain a robust regulatory function. Provide strategic advice and cross-functional support on all regulatory matters. Candidate Requirements Bachelors degree in Engineering, Life Sciences, or a health-related field. 10+ years of experience in the medical device industry, with a minimum of 3 years in a leadership or management role. In-depth knowledge of US FDA and EU medical device regulations (including MDR). Proven ability to handle complex regulatory submissions and interactions. Excellent organizational, leadership, and communication skills. A self-starter with a hands-on approach and the ability to thrive in a dynamic, entrepreneurial environment. Previous experience in an SME or medtech startup is highly desirable. For further information please contact James Cassidy or call in confidence
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Staff Specialist, Regulatory Affairs

Cork, Munster Stryker

Posted today

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Job Description

This is a 12 month contract with full Stryker benefits.
**What you will do:**
+ Assesses regulatory intelligence to assist in the development of local, regional, and global regulatory strategies Participates in advocacy activities of a technical and/or tactical nature
+ Evaluates the regulatory environment and contributes to providing internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance
+ Anticipates regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions
+ Identifies requirements and potential obstacles for market access distribution (federal, provincial/territorial state, reimbursement, purchasing groups, etc.)
+ Assists in the development of regulatory strategy and updates strategy based upon regulatory changes
+ Evaluates proposed products for regulatory classification and jurisdiction
+ Determines requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities
+ Provides regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization
+ Compares regulatory outcomes with initial product concepts and recommends changes or refinements based on initial regulatory outcomes
+ Negotiates with regulatory authorities throughout the product lifecycle
+ Identifies the need for new regulatory procedures, SOPs, and participates in development and implementation
+ Helps train stakeholders on current and new regulatory requirements to ensure organization-wide compliance
+ Assists other departments in the development of SOPs to ensure regulatory compliance
+ Provides regulatory input and technical guidance on global regulatory requirements to product development teams
+ Advises stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations
+ Assesses the acceptability of quality, preclinical, and clinical document for submission filing to comply with applicable regulations
+ Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans/strategizes (if appropriate) for changes that do not require submissions
+ Provides knowledge and guidance on preapproval inspections, GCP inspections, and clinical investigator relationships
+ Identifies, monitors, and submits applicable reports or notifications to regulatory authorities during the clinical research process
+ Provides regulatory information and guidance for proposed product claims/labeling
+ Ensures that the clinical and nonclinical data, in conjunction with regulatory strategy, are consistent with the regulatory requirements and support the proposed product claims
+ Prepares and submits electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines
+ Monitors the progress of the regulatory authority review process through appropriate communications with the agency
+ Communicates and interacts with regulatory authorities before and during the development and review of a regulatory submission through appropriate communication tools
+ Works with cross-functional teams for interactions with regulatory authorities including panel meetings and advisory committees
**What you will need:**
+ BS in Engineering, Science, or related degree; or MS in Regulatory Science
+ Typically a minimum of 4 years' experience
#IJ
This role will be posted for a minimum of 3 days.
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.
This advertiser has chosen not to accept applicants from your region.

Senior Regulatory Affairs Specialist

Dunboyne, Leinster Amicus Recruitment

Posted 2 days ago

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Job Description

Senior Regulatory Affairs Officer Pharmaceuticals (Hybrid) Location: Offices based near Dunboyne, Co. Meath, Ireland Our client, a thriving Irish pharmaceutical group, is experiencing significant growth with market-leadingOTC and Prescription medicinesacross numerous EU countries, Australia, and New Zealand. Due to their continued expansion, they are seeking a highly motivated and experiencedSenior Regulatory Affairs Officerto join their growing team. This new position reports into the Regulatory Affairs Manager and offers a fantastic opportunity to make a tangible impact within a dynamic, family-run business that prioritises performance and offers excellent career progression. What You'll Do: As a Senior Regulatory Affairs Officer, you'll play a crucial role in ensuring the company's diverse product portfolio complies with global regulatory frameworks. This is a hands-on role where you'll be expected to get stuck in and drive results. Your key responsibilities will include: Ensuring the companys products comply with all relevant regulations and standards. Demonstrating knowledge and execution ofType IA, IB, and II Variations. Managinglicence transfersin various international territories. Reviewing promotional material for medicinal products. PreparingModule 1 documentationfor National Applications. Preparing for and participating in meetings with Regulatory Authorities. Dealing with regulatory aspects of internationalising products and applying for reclassification. Training and mentoring more junior team members on Regulatory processes and compliance requirements. Monitoring and interpreting regulatory trends and changes relevant to the industry, keeping the company appraised of these. What You'll Bring: Our client is looking for a resilient and adaptable individual with a strong sense of ownership and a proven track record in regulatory affairs. Essential Experience & Knowledge: 3-4 years of progressive experiencein Regulatory Affairs within the pharmaceutical industry (human health). Demonstrable experience with pharmaceutical products, specificallyOTC and/or prescription medicines, with a focus on preparing and submitting dossiers for multiple EU countries. Exceptional attention to detail and outstanding organisational skills. Capability to work on your own initiative and take responsibility for your course of action. Whats On Offer: Competitive Salary: A highly competitive salary, negotiable based on your experience. Performance-Based Bonuses:Your hard work and contributions will be recognised and rewarded through performance-based bonuses. Hybrid Working:The company embraces a hybrid working model, requiring you in their offices near Dunboyne, Co. Meaththree days a week,with flexibility for remote work 2 days per week. They also offer flexible start and finish times around their contracted 9-5 hours to help avoid peak traffic. Career Progression:With a turnover of €250 million and ambitious growth plans, the opportunities for professional development and career advancement within the company are significant. If you're a seasoned Regulatory Affairs professional looking for a challenging yet rewarding role within a rapidly expanding pharmaceutical group, we encourage you to apply!
This advertiser has chosen not to accept applicants from your region.

Director of Regulatory Affairs

Galway, Connacht Life Science Recruitment Ltd

Posted 11 days ago

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Director of Regulatory Affairs Medical Device Start-Up Galway About the Company Our client is an ambitious, well-funded medical device start-up based in Galway, entering a critical phase of operational expansion. Backed by a proven management team with a strong track record in the start-up sector, the company is primed for significant growth both domestically and internationally. The Opportunity We are seeking a Director of Regulatory Affairs with a strong strategic vision and leadership capability to join the executive team. This is a key role where you will define and lead the companys global regulatory strategy, ensuring successful approvals and market access as the business scales rapidly. Key Responsibilities Develop and drive global regulatory strategies to support product development, commercialization, and market expansion activities. Manage all regulatory submissions (CE marking, FDA 510(k)/PMA, and other global submissions) and ensure alignment with commercial and operational timelines. Serve as the primary liaison with regulatory authorities, representing the company in all regulatory interactions and negotiations. Build and lead a high-performing regulatory team to support both early-stage product development and later-stage market access activities. Monitor and interpret evolving regulatory requirements to ensure proactive compliance across multiple geographies. Collaborate closely with cross-functional teams including R&D, Quality, Clinical, and Commercial to integrate regulatory requirements into project plans and strategic decision-making. Support due diligence and partnership activities through regulatory assessments and strategy development. About You Minimum of 10 years experience in Regulatory Affairs within the medical device industry, with at least 3 years in a leadership role. Proven success in preparing and leading regulatory submissions for Class II/III devices (EU MDR and FDA pathways essential). Strong understanding of the global regulatory environment, including emerging markets. Ability to think strategically while executing detailed regulatory plans. Exceptional leadership, communication, and stakeholder management skills. Comfortable operating in a fast-paced, high-growth, entrepreneurial environment. Degree in Life Sciences, Engineering, Regulatory Affairs, or a related technical field; Regulatory Affairs Certification (RAC) is advantageous. Whats on Offer The chance to be a key architect of the companys regulatory success during an exciting growth phase. A senior leadership role with real influence across the business. Competitive salary, equity participation, and an attractive benefits package. An entrepreneurial, high-energy culture with a leadership team known for successful start-up growth and exits. If interested in discussing further please contact James Cassidy or call in confidence
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Sr Mgr Regulatory Affairs

Dublin, Leinster Regeneron Ireland DAC

Posted 11 days ago

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At Regeneron, we're advancing science and medicine to improve lives. We're seeking a talented Regulatory Affairs Manager to join our team and play a pivotal role in supporting EU regulatory activities for oncology drug development. This is your chance to contribute to groundbreaking clinical development programs while collaborating with global experts and building relationships across the EU regulatory network. Join us in shaping the future of oncology treatments and making a meaningful impact on patients' lives. A Typical Day: As a Regulatory Affairs Manager, your day might include: Developing regulatory strategies for oncology programs by researching guidelines, EU precedents, and emerging trends. Managing CTA submissions via CTIS for multiple EU member states, ensuring compliance with EU requirements. Organizing, preparing, and reviewing CTA amendments, annual reports, and other regulatory documents. Performing critical analyses of clinical and preclinical data to develop interpretations and conclusions. Leading EU Scientific Advice requests and coordinating EMA and EU national agency meetings. Monitoring newly published EU Commission and EMA guidelines to ensure compliance and provide training for scientific staff. Representing Regeneron Regulatory Affairs in engagements with EMA scientific committees, EU national agencies, and industry associations. This Role May Be For You If: You are someone who: Thrives in a collaborative environment and enjoys working with multidisciplinary teams. Has a proven ability to navigate EU regulatory frameworks and requirements. Is detail-oriented and skilled in analyzing clinical and preclinical data. Has experience leading regulatory agency meetings and negotiating effectively with stakeholders. Is passionate about contributing to oncology drug development programs. Values continuous learning and stays updated on emerging regulatory trends. Has excellent written and verbal communication skills. To Be Considered: We're looking for candidates with: An advanced degree in a scientific discipline. At least 4 years of regulatory experience, with a focus on clinical development. Proven experience supporting EU Clinical Trial Applications through approval and study start-up. Familiarity with EMA processes such as scientific advice, orphan designation, and PIPs. Experience in oncology regulatory strategy is an advantage. A strong ability to negotiate and express clear positions to stakeholders at all levels. Preferred qualifications include experience with marketing authorization applications or life-cycle management of approved products in the centralized procedure. Why Join Us? At Regeneron, we believe in fostering innovation, collaboration, and growth. You'll have the opportunity to work with a passionate team dedicated to advancing science and improving patient outcomes. Together, we'll make a difference. Does this sound like you? Apply now to take your first step towards living the Regeneron Way. We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U. positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
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Quality & Regulatory Affairs Co-Op Placement 2026 - Cork

Carrigtwohill, Munster Stryker

Posted today

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Job Description

This position provides experience of working in a regulated medical device company. You will have the opportunity to develop and apply basic knowledge and understanding of the quality, regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures.
Additionally, this opportunity provides good knowledge of **EU Medical Device Directive 93/42/EEC, EU Medical Device Regulation 2017/745 and US regulatory requirements** across a wide range and classification of products. Through this, it is possible to see how these regulations are implemented in practice in industry.
Throughout the placement, you will be an integral part of Stryker's 2025 Cooperative cohort.
_Tasks and responsibilities may include:_
+ Together, with your Stryker team leader and college supervisor, identify a **Q** **uality/R** **egulatory** **A** **ffairs** improvement project along with project objectives, scope, success factors, milestones and evaluation
+ Communicates **project updates** and presents at the relevant project review forums
+ Assists in the development of **regulatory procedures** and best practices
+ Assists in the preparation of **technical documentation** and **submission packages** for regulatory agencies
+ Ensures compliance with the **Quality and Safety systems**
+ As a student, effectively adapts to practically working in a workplace by being **dependable, punctual, hardworking,** **organised** and a **team-player** with the ability to **take initiative**
**What you will need:**
+ Currently completing an Irishor Northern Irish university qualification in **Engineering or Science or other related** **courses**
+ **Honesty and** **i** **ntegrity** ; must comply with the quality system, regulations, and company policies
+ **Self-motivated, flexible, and hardworking** - enjoys working in a dynamic, fast and results orientated environment
+ **Reliable, dependable, and punctual**
+ Organised, focused, and capable of **multi-tasking**
+ Good **analytical** and **problem-solving skills**
+ **Good verbal and written communication** skills as well as **basic PC skills**
+ Is a **team player** and capable of working as part of a **multi-disciplined team**
+ Available for either **6, 9 or 12 months** - exact duration and start date to be discussed with your Talent Acquisition Business Partner at Stryker
**What we can offer:**
+ Attractive **salary** & **vacation** entitlement
+ Experience **our inclusive, people-first culture** . You will be paired with mentors and have access to leaders who **support your growth, give constructive feedback, and help build confidence.**
+ **Flexible** working hours
+ **Sports & Social** clubs and DE&I **Employee Resource Groups**
+ The opportunity to contribute to **real-world projects** that make a difference in improving **healthcare and patients' lives.** In Stryker, you will be given responsibilities that truly matter.
**Next steps:**
+ Once you have applied to one of our co-op opportunities, our dedicated University Recruiting Business Partners will take some time to look through your application and ensure you meet the criteria in relation to the specific position.
+ Should all requirements be met, and you are happy to proceed, in September, successful candidates will be invited to a final round business interview with the hiring team.
+ If successful through the final round business interview, you will receive your offer shortly after
+ Please note, individual recruitment timelines may vary - please keep in contact with your University Recruiting Business Partner and your university placement coordinator for specific timelines and updates
This role will be posted for a minimum of 3 days.
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.
This advertiser has chosen not to accept applicants from your region.

Quality & Regulatory Affairs Co-Op Placement 2026 - Cork

Cork, Munster Stryker

Posted today

Job Viewed

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Job Description

This position provides experience of working in a regulated medical device company. You will have the opportunity to develop and apply basic knowledge and understanding of the quality, regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures.
Additionally, this opportunity provides good knowledge of **EU Medical Device Directive 93/42/EEC, EU Medical Device Regulation 2017/745 and US regulatory requirements** across a wide range and classification of products. Through this, it is possible to see how these regulations are implemented in practice in industry.
Throughout the placement, you will be an integral part of Stryker's 2025 Cooperative cohort.
_Tasks and responsibilities may include:_
+ Together, with your Stryker team leader and college supervisor, identify a **Q** **uality/R** **egulatory** **A** **ffairs** improvement project along with project objectives, scope, success factors, milestones and evaluation
+ Communicates **project updates** and presents at the relevant project review forums
+ Assists in the development of **regulatory procedures** and best practices
+ Assists in the preparation of **technical documentation** and **submission packages** for regulatory agencies
+ Ensures compliance with the **Quality and Safety systems**
+ As a student, effectively adapts to practically working in a workplace by being **dependable, punctual, hardworking,** **organised** and a **team-player** with the ability to **take initiative**
**What you will need:**
+ Currently completing an Irishor Northern Irish university qualification in **Engineering or Science or other related** **courses**
+ **Honesty and** **i** **ntegrity** ; must comply with the quality system, regulations, and company policies
+ **Self-motivated, flexible, and hardworking** - enjoys working in a dynamic, fast and results orientated environment
+ **Reliable, dependable, and punctual**
+ Organised, focused, and capable of **multi-tasking**
+ Good **analytical** and **problem-solving skills**
+ **Good verbal and written communication** skills as well as **basic PC skills**
+ Is a **team player** and capable of working as part of a **multi-disciplined team**
+ Available for either **6, 9 or 12 months** - exact duration and start date to be discussed with your Talent Acquisition Business Partner at Stryker
**What we can offer:**
+ Attractive **salary** & **vacation** entitlement
+ Experience **our inclusive, people-first culture** . You will be paired with mentors and have access to leaders who **support your growth, give constructive feedback, and help build confidence.**
+ **Flexible** working hours
+ **Sports & Social** clubs and DE&I **Employee Resource Groups**
+ The opportunity to contribute to **real-world projects** that make a difference in improving **healthcare and patients' lives.** In Stryker, you will be given responsibilities that truly matter.
**Next steps:**
+ Once you have applied to one of our co-op opportunities, our dedicated University Recruiting Business Partners will take some time to look through your application and ensure you meet the criteria in relation to the specific position.
+ Should all requirements be met, and you are happy to proceed, in September, successful candidates will be invited to a final round business interview with the hiring team.
+ If successful through the final round business interview, you will receive your offer shortly after
+ Please note, individual recruitment timelines may vary - please keep in contact with your University Recruiting Business Partner and your university placement coordinator for specific timelines and updates
This role will be posted for a minimum of 3 days.
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.
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  48. perm_media Media & PR
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  61. science Scientific Research & Development
  62. wifi Telecoms
  63. psychology Therapy
  64. pets Veterinary
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