What Jobs are available for Regulatory Framework in Ireland?

Want to help us help others? We're hiring
GoFundMe is the world's most powerful community for good, dedicated to helping people help each other. By uniting individuals and nonprofits in one place, GoFundMe makes it easy and safe for people to ask for help and support causes—for themselves and each other. Together, our community has raised more than $40 billion since 2010.

Join us The GoFundMe team is searching for our next Regulatory Affairs Analyst to help interpret regulatory changes and ensure our products, policies, and communications comply with all relevant laws and standards. This includes preparing reports, documentation, and responses to regulatory agencies while collaborating across teams to integrate compliance into product planning.

Already part of our team? We ask that internal candidates apply via the internal job board to ensure your application is reviewed appropriately.

The Job

• Conduct complex investigations into potential financial crimes, including fraud, money laundering, and sanctions compliance, using advanced data analysis and research methodologies.
• Lead comprehensive investigations, gathering evidence, analyzing user and transaction behavior, and working cross-functionally to mitigate risks.
• Analyze large, complex datasets to detect suspicious activity, leveraging advanced analytical tools and techniques.
• Provide legislative analysis to ensure compliance with emerging laws and regulations, interpreting their impact on financial crime prevention strategies, donation volume, and customer experience.
• Prepare detailed investigative and legislative reports for senior management, law enforcement, and regulatory authorities, clearly documenting findings and recommendations.
• Collaborate with internal teams (compliance, legal, risk) and external law enforcement or regulatory bodies to manage financial crime cases.
• Stay informed on new financial crime trends and legislative changes, contributing to the improvement of policies and procedures for fraud detection and prevention.

You

• 1-2 years of experience in financial crime investigations, data analysis, or compliance.
• Bachelor's degree in Data Science, Economics, Finance, Criminal Justice, Mathematics, or a related field.
• Strong proficiency in data analysis tools (e.g. Looker, SQL, Excel) and transaction monitoring systems.
• Knowledge of financial crime laws and regulations, including AML, KYC, and sanctions compliance, and experience with legislative analysis.
• Ability to synthesize complex data and legal information into actionable insights.
• Excellent written and verbal communication skills, with the ability to present findings clearly to both technical and non-technical audiences.
• Fluency in English and one of either: Spanish, French, German, or Italian
• Professional certifications such as CAMS (Certified Anti-Money Laundering Specialist) or equivalent are a plus.
• Strong ethical standards and discretion when handling sensitive information.

Preferred

• Experience liaising with law enforcement or regulatory agencies on financial crime investigations.
• Familiarity with machine learning or AI-driven tools for fraud detection and their attendant regulations.
• Uncommon ability to anticipate, adapt, and respond to sensitive and evolving situations while balancing numerous, often competing, priorities.

Why you'll love it here

• Make an Impact: Be part of a mission-driven organization making a positive difference in millions of lives every year.
• Innovative Environment: Work with a diverse, passionate, and talented team in a fast-paced, forward-thinking atmosphere.
• Collaborative Team: Join a fun and collaborative team that works hard and celebrates success together.
• Competitive Benefits: Enjoy competitive pay and comprehensive healthcare benefits.
• Holistic Support: Enjoy financial assistance for things like hybrid work, family planning, along with generous parental leave, flexible time-off policies, and mental health and wellness resources to support your overall well-being.
• Growth Opportunities: Participate in learning, development, and recognition programs to help you thrive and grow.
• Commitment to DEI: Contribute to diversity, equity, and inclusion through ongoing initiatives and employee resource groups.
• Community Engagement: Make a difference through our volunteering program.

We live by our core values:
impatient to be great
,
find a way
,
earn trust every day
,
fueled by purpose
. Be a part of something bigger with us

GoFundMe is proud to be an equal opportunity employer that actively pursues candidates of diverse backgrounds and experiences. We do not discriminate on the basis of race, color, religion, ethnicity, nationality or national origin, sex, sexual orientation, gender, gender identity or expression, pregnancy status, marital status, age, medical condition, mental or physical disability, or military or veteran status.

If you require a reasonable accommodation to complete a job application or a job interview or to otherwise participate in the hiring process, please contact us at

Global Data Privacy Notice For Job Candidates And Applicants
Depending on your location, the General Data Protection Regulation (GDPR) or certain US privacy laws may regulate the way we manage the data of job applicants. Our full notice outlining how data will be processed as part of the application procedure for applicable locations is available here. By submitting your application, you are agreeing to our use and processing of your data as required.

Learn More About GoFundMe
We're proud to partner with , an independent public charity, to extend the reach and impact of our generous community, while helping drive critical social change. You can learn more about 's activities and impact in their FY '24 annual report.

Our annual "Year in Help" report reflects our community's impact in advancing our mission of helping people help each other.

For recent company news and announcements, visit our Newsroom.

Comply Guru offer transformative training in the Life Sciences Industry. We are looking for suitable candidates for a fulltime role as a Regulatory Affairs Specialist. The ideal candidate will join a team of highly motivated, passionate people who are creating
industry-leading
learning solutions for a global audience.

The Regulatory Affairs Specialist supports the QA/RA Director in ensuring Comply Guru's training programs, processes, and products meet applicable quality and regulatory requirements. This role focuses on maintaining up to date regulatory content, supporting accreditation activities, and contributing to the implementation and continual improvement of the company's Quality Management System (QMS).

The ideal candidate is detail orientated, organized, and passionate about regulatory compliance, quality standards within MedTech and training.

**This role requires work authorization in Ireland - only apply if authorized to work in Ireland**

This role is a hybrid working position. High-speed internet connection essential.

Key Responsibilities:

Regulatory Affairs

• Support maintenance and development of course content and training materials related to regulatory affairs (e.g., MDSAP, MDR, FDA, QSR/QMSR, ISO 13485)
• Research and monitor changes to relevant international regulations and standards; assist in updating training materials and internal documentation accordingly
• Prepare regulatory documentation and evidence as required for audits, accreditation renewals, and partner reviews (CQI, IRCA, RAPS, Exemplar Global, or equivalent)
• Assist in maintaining Comply Guru's accreditation as an Approved Training Partner by ensuring compliance with relevant external bodies
• Support communication of key regulatory updates to the QA/RA Director and internal stakeholders.

Quality Management System (QMS)

• Assist in implementing, maintaining, and improving the ISO 9001 based QMS to support certification and compliance objectives
• Maintain controlled documents, records, and logs in accordance with quality system procedures
• Support internal audit activities and follow-up actions
• Participate in CAPA (Corrective and Preventive Action) and continuous improvement initiatives

Training

• Collaborate with internal teams and external Subject Matter Experts to ensure regulatory course content remains current, accurate, and compliant
• Support development and lead delivery of instructor-led workshops
• Provide learner support on regulatory training courses where applicable

General

• Maintain professional development to stay current with relevant standards, regulations, and best practices
• Support company initiatives, webinars, blogs, and other thought leadership activities related to QA/RA
• Perform other duties as assigned by the CEO and/or QA/RA Director

Essential Skills and Experience

• Minimum 4 years' experience working within regulated industries (MedTech, QA/RA roles etc.)
• Strong understanding of international regulatory frameworks (MDR, MDSAP, FDA QSR/QMSR, ISO 13485, ISO 9001)
• Experience working within a QMS (preferably ISO 9001 or ISO 13485)
• Excellent attention to detail and ability to manage multiple projects simultaneously
• Strong written and verbal communication skills, with the ability to interpret and communicate complex regulatory information clearly
• Competent in MS Office and document control systems
• Self-motivated and proactive, with a focus on compliance and quality improvement
• Collaborative and team-oriented, with a willingness to learn and take initiative
• Strong organizational and problem-solving skills
• Committed to maintaining high standards of professional ethics and integrity
• Adaptable in a fast-paced, growing business environment

Preferred Qualifications

• Bachelor's degree in Science, Engineering, Quality, or a related discipline (beneficial)
• Recognized training in Quality and Regulatory Affairs e.g. CQI-IRCA Certified MD-QMS Lead Auditor, MDSAP, MDR, or equivalent (beneficial)
• Train the Trainer certification (beneficial)

Benefits

• Bonus, Healthcare & Pension

Want to help us help others? We're hiring
GoFundMe is the world's most powerful community for good, dedicated to helping people help each other. By uniting individuals and nonprofits in one place, GoFundMe makes it easy and safe for people to ask for help and support causes—for themselves and each other. Together, our community has raised more than $40 billion since 2010.

Join us The GoFundMe team is searching for our next Regulatory Affairs Analyst to help interpret regulatory changes and ensure our products, policies, and communications comply with all relevant laws and standards. This includes preparing reports, documentation, and responses to regulatory agencies while collaborating across teams to integrate compliance into product planning.

Already part of our team? We ask that internal candidates apply via the internal job board to ensure your application is reviewed appropriately.

The Job

• Conduct complex investigations into potential financial crimes, including fraud, money laundering, and sanctions compliance, using advanced data analysis and research methodologies.
• Lead comprehensive investigations, gathering evidence, analyzing user and transaction behavior, and working cross-functionally to mitigate risks.
• Analyze large, complex datasets to detect suspicious activity, leveraging advanced analytical tools and techniques.
• Provide legislative analysis to ensure compliance with emerging laws and regulations, interpreting their impact on financial crime prevention strategies, donation volume, and customer experience.
• Prepare detailed investigative and legislative reports for senior management, law enforcement, and regulatory authorities, clearly documenting findings and recommendations.
• Collaborate with internal teams (compliance, legal, risk) and external law enforcement or regulatory bodies to manage financial crime cases.
• Stay informed on new financial crime trends and legislative changes, contributing to the improvement of policies and procedures for fraud detection and prevention.

You

• 1-2 years of experience in financial crime investigations, data analysis, or compliance.
• Bachelor's degree in Data Science, Economics, Finance, Criminal Justice, Mathematics, or a related field.
• Strong proficiency in data analysis tools (e.g. Looker, SQL, Excel) and transaction monitoring systems.
• Knowledge of financial crime laws and regulations, including AML, KYC, and sanctions compliance, and experience with legislative analysis.
• Ability to synthesize complex data and legal information into actionable insights.
• Excellent written and verbal communication skills, with the ability to present findings clearly to both technical and non-technical audiences.
• Fluency in English and one of either: Spanish, French, German, or Italian
• Professional certifications such as CAMS (Certified Anti-Money Laundering Specialist) or equivalent are a plus.
• Strong ethical standards and discretion when handling sensitive information.

Preferred

• Experience liaising with law enforcement or regulatory agencies on financial crime investigations.
• Familiarity with machine learning or AI-driven tools for fraud detection and their attendant regulations.
• Uncommon ability to anticipate, adapt, and respond to sensitive and evolving situations while balancing numerous, often competing, priorities.

Why you'll love it here

• Make an Impact: Be part of a mission-driven organization making a positive difference in millions of lives every year.
• Innovative Environment: Work with a diverse, passionate, and talented team in a fast-paced, forward-thinking atmosphere.
• Collaborative Team: Join a fun and collaborative team that works hard and celebrates success together.
• Competitive Benefits: Enjoy competitive pay and comprehensive healthcare benefits.
• Holistic Support: Enjoy financial assistance for things like hybrid work, family planning, along with generous parental leave, flexible time-off policies, and mental health and wellness resources to support your overall well-being.
• Growth Opportunities: Participate in learning, development, and recognition programs to help you thrive and grow.
• Commitment to DEI: Contribute to diversity, equity, and inclusion through ongoing initiatives and employee resource groups.
• Community Engagement: Make a difference through our volunteering and Gives Back programs.

We live by our core values:
impatient to be great
,
find a way
,
earn trust every day
,
fueled by purpose
. Be a part of something bigger with us

GoFundMe is proud to be an equal opportunity employer that actively pursues candidates of diverse backgrounds and experiences. We do not discriminate on the basis of race, color, religion, ethnicity, nationality or national origin, sex, sexual orientation, gender, gender identity or expression, pregnancy status, marital status, age, medical condition, mental or physical disability, or military or veteran status.

If you require a reasonable accommodation to complete a job application or a job interview or to otherwise participate in the hiring process, please contact us at

Global Data Privacy Notice For Job Candidates And Applicants
Depending on your location, the General Data Protection Regulation (GDPR) or certain US privacy laws may regulate the way we manage the data of job applicants. Our full notice outlining how data will be processed as part of the application procedure for applicable locations is available here. By submitting your application, you are agreeing to our use and processing of your data as required.

Learn More About GoFundMe
We're proud to partner with , an independent public charity, to extend the reach and impact of our generous community, while helping drive critical social change. You can learn more about 's activities and impact in their FY '24 annual report.

Our annual "Year in Help" report reflects our community's impact in advancing our mission of helping people help each other.

For recent company news and announcements, visit our Newsroom.

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

Medtronic

At Medtronic, we value what makes you unique. Be part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.

Our Purpose

At our Regulatory Affairs department in Medtronic, plc, based in Galway our mission is to develop innovative strategies for regulatory approval, anticipate and respond to changing regulatory requirements, and provide strategic leadership to influence the global regulatory environment to benefit the patients we serve. Regulatory Affairs is a key function within the business and this role is supporting the Structural Heart (SH) business.

Come for a job, stay for a career

A Day in The Life Of:

• Directs or performs coordination and preparation of document packages for regulatory submissions.
• Teams with other Regulatory Affairs Specialists and international regulatory specialists to provide regulatory support for changes to existing products.
• Work with engineers and technical experts to develop robust regulatory strategies and resolve questions from regulatory agencies.
• Leads or compiles all materials required in submissions, license renewal and annual registrations.
• Supports change control activities to support global approval and implementation of product and process changes.
• Recommends changes for labelling, manufacturing, marketing, and clinical protocol/evaluation reports for regulatory compliance.
• Keeps abreast of regulatory procedures and changes. Develop internal procedures to ensure continuous compliance with all regulatory requirements.
• May direct interaction with regulatory agencies on defined matters.
• Support regulatory compliance activities, including manufacturing site registration & GMP audits as needed.
• Monitors and improves tracking/control systems.
• Identifies and develops best practices within the Regulatory Affairs Department including continuous development initiatives.

Key Skills & Experience

• We are looking for a person qualified to Level 8 Science or Engineering honours bachelor's degree and minimum of 2 years of relevant experience.
• Regulatory Affairs qualification is desirable, but not mandatory.
• Regulatory experience in Medical Devices and/or Pharmaceuticals is required.
• You are a dynamic team player and can work effectively and proactively on activities both individually and in teams.
• You have strong technical knowledge. You are skilled in thinking critically and making sound decisions.
• You collaborate with others and create alignment with team members.
• You set high standards and drive accountability in the execution of your responsibilities, and you model ethical behaviour.
• Ability to work independently and under general direction only.
• Strong proficiency skills with I.T systems and data collection.

Medtronic offer a competitive salary and flexible Benefits Package

#IJ

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

Medtronic offers a competitive Salary and flexible Benefits Package

A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.

Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people.

We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

I am partnering with
Abbott Rapid Diagnostics
to hire a
Regulatory Affairs Specialist II
on an initial on
12 month contract
to
support an exciting new project.

Working Model: Remote

Overview

For the Abbott Rapid Diagnostics Infectious Disease Business Unit, we are looking for a talented and dynamic Regulatory professional to coordinate and manage all related RA activities for the Abbott portfolio in a designated list of countries as part of the EU RA regional team.

Responsibilites

· Support and develop regulatory submission plan for the region in terms of IVDR transition project in collaboration with Global RA IVDR project team, Legal manufacturing sites, supply chain, marketing, commercial and in country Distributors.

· Assist to manage applicable change control projects for regional team by working closely with relevant manufacturing sites and other functions to obtain all necessary dossiers to support product registration, or amendment to existing product certificates and maintain database with risk escalation if necessary.

· Track applicable regulatory milestones in internal Regulatory database per defined Key Performance Indicators.

· Represent RA and/or region at relevant meetings such as IVDR meetings or change control meetings.

· Provide secondary support as backup towards local Regulatory Affairs matters as applicable.

· Support Abbott strategic Quality and Regulatory Affairs Goals and objectives.

· Monitor developing regulations and gather regulatory intelligence that may be relevant to the business.

· Perform ad hoc duties as deemed necessary for the position and business.

Qualifications

· BSc or equivalent.

· A minimum of 2 years' experience in Regulatory Affairs, preferably in Medical Devices, ideally in IVDs.

Competencies and Attributes

· Demonstrable working knowledge of the pharmaceutical industry in the regions they will support.

· Demonstrated capacity in project management.

· Ability to navigate in a cross-functional environment.

· Knowledge of the regulatory environment in European Union (MDR/IVDR, local legislation, industry standards and guidance).

· Excellent written and oral communication skills in English.

· Attention to detail.

· Strong interpersonal skills.

· Highest levels of integrity and diplomacy.

· Capacity to maintain the highest levels of confidentiality internally and externally.

Position Title:
Regulatory Affairs Specialist

(This position will not involve people management; therefore, the title is "Specialist")

Reports To:
General Manager of ARKRAY IRELAND LIMITED

Role Summary

ARKRAY is looking for an experienced Regulatory Affairs Specialist who can act as the Authorized Representative regarding the Person Responsible for Regulatory Compliance defined in the European IVDR. When joining ARKRAY as its regulatory member in Europe, you will function independently as the key contact for regulatory issues within Europe, but will also be working closely with the Quality Team in Ireland, Japan Headquarters, and its other overseas members to share knowledge and expertise in support of team activities.

Duties and Responsibilities

PRRC

• Ensure the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released.
• Ensure the technical documentation and the EU declaration of conformity are drawn up and kept up to date.
• Ensure the post-market surveillance and vigilance reporting obligations are complied with in accordance with IVDR and cooperate with those involved.

Regulatory Affairs

• Provide guidance and interpretation of IVDR requirements for the design and development of new products. Recommend and implement compliance strategies for existing, new, and proposed products or product changes.
• Act as the main point of contact between ARKRAY companies and Notified Bodies/Competent Authorities for new product development and changes to existing products.
• a) Work closely with the Regulatory Affairs and Quality Management teams in Japan to establish robust regulatory/quality systems that comply with IVDR.
• b) Work closely with the Design and Development teams in Japan to ensure the implementation of requirements from IVDR.
• c) Assist and coordinate product performance evaluations or clinical trials in Europe.
• d) Review and approve technical documents to assemble an IVDR-compliant technical file and keep them up to date.

Knowledge and Skills

Required/Preferred

• Four years of professional experience in European regulatory affairs or quality systems management related to medical devices.
• English business level or above.
• Experience in IVDR for Class A, B, and C products, such as Laboratory and Point of Care IVD products.
• Experience with ISO, GMP/QSR, and other regulatory issues related to IVD medical products.
• MDR regulatory and/or Quality System Management experience preferred.

Working Location

ARKRAY IRELAND LIMITED.

First Floor, , Sir John Rogerson's Quay, Dublin 2, Dublin, D02 Kv60, Ireland

We are currently working with a client in the medical device sector who is seeking an experienced
Regulatory Affairs Manager
to join their team in Galway. This is a fantastic opportunity to play a key role in shaping regulatory strategy and ensuring successful product approvals for innovative medical technologies.

The Role

As
Regulatory Affairs Manager
, you will be responsible for driving regulatory compliance activities, leading submissions, and building strong relationships with regulatory bodies. The role requires a mix of regulatory expertise, leadership, and a hands-on approach.

Key Responsibilities

• Define and execute regulatory strategy for new and existing products.
• Lead regulatory filings including 510(k), CE mark submissions, product registrations, and regulatory interactions.
• Build and maintain strong relationships with the FDA, Notified Bodies, and other regulatory agencies.
• Monitor regulatory changes and adapt company strategy accordingly.
• Collaborate with Quality Assurance on post-market surveillance and vigilance activities in Europe and the US.
• Review and approve advertising and promotional materials from a regulatory standpoint.
• Provide strategic regulatory guidance to the wider leadership team.
• Manage and develop resources within the regulatory function.

What We're Looking For

• Degree in Engineering, Science, or a health-related discipline.
• 10+ years' experience in the medical device industry, including at least 3 years in a management role.
• Strong knowledge of US and EU regulatory requirements (510(k), CE Mark, FDA, Notified Body interactions).
• Proven leadership, coaching, and mentoring skills.
• Excellent organisational, problem-solving, and prioritisation abilities.
• Strong communication and interpersonal skills.
• Experience in an SME or start-up environment is an advantage.
• A proactive, hands-on mindset.

CMC Consultant

職務内容:

• プロジェクトリーダーの指示のもと、新薬開発段階での開発戦略及びCMC薬事戦略策定から製造販売承認申請及び承認取得後の製品の変更管理に関わるCMC薬事業務全般。また、クライントと協議、交渉を行う。

業務内容

• 薬剤開発におけるCMC関連の既存成績並びに情報の分析並びに評価

• 日本での臨床開発計画及び薬事申請のためのCMC薬事戦略の策定。

• 製造販売承認申請資料(新規申請、一変申請及び軽微変更届)の作成及び申請。
• PMDA相談資料作成及び規制当局との照会事項対応。
• 申請後の照会事項対応及びPMDAとの対応支援を行い、製造販売承認を取得。
• 医薬品原薬等登録原簿(MF)及び外国製造業者認定(FMA)手続きの支援
• GMP適合性調査サポート
• カルタヘナ法に係る申請手続きの支援
• 医薬品原薬等登録原簿の国内管理人業務(変更管理における薬事評価を含む)
• 様々な薬事コンサルティング

条件:

• 製薬会社における医薬品開発(もしくはCROでの勤務)におけるCMC薬事経験3年以上
• 製薬会社における製剤開発又は分析研究等のCMC研究経験、または製造施設での品質管理(製造管理、分析・試験)等の経験
• 製造販売承認申請書作成、CTD作成、医薬品原薬等登録原簿の作成などの経験
• 生物製剤に関するCMC経験者なら、尚可
• 最終学歴: 大学卒(薬学もしくはその他の自然科学分野の専攻

Clinical Consultant

職務内容:

・プロジェクトリーダーの指示のもと、Gap分析レポート作成、開発戦略策定、PMDA相談資料、申請資料等の作成を行う

・必要に応じて、クライントと協働し、規制当局との交渉を実施する

・日本国内における医薬品開発ならびに薬事申請を、社内の業務手順を遵守し、高い品質をもって推進する

業務内容

・薬剤開発における既存成績並びに情報の分析並びに評価

・日本での臨床開発計画をクライントと協働し、策定する

・日本の薬事規制に関する社内外からの問い合わせに対し回答及び助言を行う

・国内治験管理人として臨床試験を監督し、適宜助言を行う

・新医薬品の製造販売承認申請に関し、CTD資料作成(添付文書案等のModule1関連の資料作成を含む)を行い、クライアントと協働して、申請後の照会事項対応及びPMDAとの対応支援を実施し、製造販売承認を取得する

・クライントと協働して、PMDA対面助言を実施、規制当局との折衝を行なう

・薬事規制の調査及びコンサルテーション

必須条件:

・製薬会社もしくはCROでのPMDA対面助言の実施、規制当局との折衝の経験

・治験届出業務、承認申請及び添付文書作成等の経験

・バイオシミラー、医療機器、後発品開発申請、再生医療等製品の経験も、考慮する

・最終学歴: 大学卒以上(薬学もしくはその他の自然科学分野の専攻)

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