13 Policy Lead jobs in Ireland
Regulatory Affairs Manager

Posted today
Job Viewed
Job Description
**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.
Regulatory Affairs Manager
Posted 2 days ago
Job Viewed
Job Description
Regulatory Affairs Manager
Posted 2 days ago
Job Viewed
Job Description
Regulatory Affairs Manager
Posted 2 days ago
Job Viewed
Job Description
Staff Specialist, Regulatory Affairs

Posted today
Job Viewed
Job Description
**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.
Senior Regulatory Affairs Specialist
Posted 2 days ago
Job Viewed
Job Description
Director of Regulatory Affairs
Posted 11 days ago
Job Viewed
Job Description
Be The First To Know
About the latest Policy lead Jobs in Ireland !
Sr Mgr Regulatory Affairs
Posted 11 days ago
Job Viewed
Job Description
Quality & Regulatory Affairs Co-Op Placement 2026 - Cork

Posted today
Job Viewed
Job Description
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.
Quality & Regulatory Affairs Co-Op Placement 2026 - Cork

Posted today
Job Viewed
Job Description
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.