Regulatory Affairs Professional
8 hours ago
Support the work of the company and project teams in the provision of specialised regulatory expertise to client companies, ensuring that internal procedures and client expectations and interests are met. Bring considerable experience in IVD/CDx development, validation and approval to client organisations, providing expert strategies and guidance to their development programmes.
Research and prepare elements of regulatory submission documents on behalf of client companies, including but not limited to IVDR Annex XIV applications, CTAs, study risk determination requests, IDE submissions, 510(k), PMA, CE Technical Files and Design Dossiers, PMDA Briefing Documents and Submissions etc.
Conduct gap analyses on behalf of client companies and prepare associated reports (e.g. technical documentation/design history files). Contribute to the preparation of global guidance documents and white papers. Contribute to the preparation of other regulatory documents on behalf of client companies (e.g., Performance Evaluation Plans/Reports, Investigator Brochures, etc).
-
Global Regulatory Affairs Professional
2 weeks ago
Belfast, United Kingdom ARC Regulatory Ltd Full timeRole OverviewThe Global Regulatory Affairs Professional will play a critical role in developing and implementing global regulatory strategies for IVD devices, ensuring compliance with key global markets. As a Senior Specialist in Regulatory Affairs, you will be responsible for providing specialized regulatory expertise to client companies, ensuring...
-
Regulatory Affairs Specialist
1 day ago
Belfast, United Kingdom ARC Regulatory Ltd Full timeARC Regulatory LtdWe are seeking a highly experienced Regulatory Affairs Specialist to join our team in Belfast. As a key member of our compliance solutions delivery team, you will play a critical role in ensuring that client companies meet their regulatory obligations and objectives.The ideal candidate will have a strong background in IVD/CDx development,...
-
Regulatory Affairs Specialist
4 weeks ago
Belfast, United Kingdom HIRANI Full timeRegulatory Affairs SpecialistHirani is seeking a highly experienced Regulatory Affairs Specialist to join our team. As a Senior Clinical Project Manager, you will be responsible for providing expert guidance on clinical regulatory matters, including clinical study design, conduct, and reporting. Your responsibilities will also include developing and...
-
Regulatory Affairs Specialist
4 weeks ago
Belfast, United Kingdom HIRANI Full timeSenior Specialist – Regulatory Affairs (IVD/CDx)Hirani ARC Regulatory seeks highly skilled and experienced regulatory professionals to join our team.The Role:Provide specialized regulatory expertise to client companies, ensuring compliance with internal procedures and client expectations.Conduct thorough research and prepare regulatory submission documents...
-
Regulatory Affairs Specialist Opportunity
3 weeks ago
Belfast, United Kingdom Lifelancer Full timeAre you looking for a challenging and rewarding career in regulatory affairs?We are seeking a highly motivated and organized Regulatory Affairs Co-op to join our team at Stryker Belfast. As a key member of our HeartSine AED Regulatory Affairs team, you will play a vital role in upholding Stryker's reputation as the leading provider of public access...
-
Senior Regulatory Consultant
2 days ago
Belfast, United Kingdom ARC Regulatory Ltd Full timeCareer OpportunityWe are seeking a highly experienced Regulatory Affairs Specialist to join our team in Belfast. This is an exciting opportunity for a motivated and detail-oriented individual to join our dynamic team and contribute to the growth and success of ARC Regulatory Ltd.The successful candidate will have a strong background in IVD/CDx development,...
-
Regulatory Affairs Specialist
1 day ago
Belfast, United Kingdom CV Library Full timeRegulatory Affairs Specialist Job OpportunityWe are seeking a Regulatory Affairs Specialist to join our team in Belfast. The successful candidate will assist in the smooth running of the team and carry out a range of governance-related work in supporting regulated entities.Main Responsibilities:Provide company secretarial support, including preparing meeting...
-
Regulatory Compliance Expert
2 weeks ago
Belfast, United Kingdom ARC Regulatory Ltd Full timeAbout the RoleWe are seeking a highly experienced Regulatory Compliance Expert to join our team at ARC Regulatory Ltd. As a Senior Specialist in Regulatory Affairs, you will be responsible for providing specialized regulatory expertise to client companies, ensuring compliance with global regulations and standards.Key ResponsibilitiesConduct regulatory...
-
Regulatory Affairs Specialist
21 hours ago
Belfast, United Kingdom Spence & Partners Ltd. Full timeSpence & Partners Ltd. is seeking a skilled Regulatory Affairs Specialist to join their team in the UK. As a Regulatory Affairs Specialist, you will play a key role in ensuring that our organization operates in a compliant, legal, and ethical manner.The estimated salary for this position is £45,000 - £55,000 per annum, depending on experience. In this...
-
Senior Regulatory Professional
4 weeks ago
Belfast, United Kingdom HIRANI Full timeSenior Regulatory Affairs AssociateHirani ARC Regulatory invites experienced regulatory professionals to apply for this challenging role.About the Role:Support the development of regulatory strategies for client companies, ensuring alignment with global regulations.Research and prepare regulatory submission documents, including CTA's and study risk...
-
Regulatory Affairs Expert
3 weeks ago
Belfast, United Kingdom Citigroup Inc. Full timeCitigroup Inc. is seeking a highly skilled Regulatory Affairs Expert to join their team in analyzing and drafting regulatory content.In this role, you will review regulations, draft publications, and collaborate with colleagues to ensure the Firm's regulatory obligations are accurately captured in its inventory.The successful candidate will have a strong...
-
Regulatory Affairs Professional
1 week ago
Belfast, United Kingdom Lifelancer Full timeJob Overview">Stryker, a global leader in medical technologies, is seeking a Regulatory Affairs Professional to join its team in Belfast, UK. As a key member of the HeartSine AED Regulatory Affairs team, you will play a crucial role in upholding Stryker's reputation as the leading provider of Public Access Defibrillators.The successful candidate will be...
-
Regulatory Affairs Expert
4 weeks ago
Belfast, United Kingdom Abacus Professional Recruitment Full timeA Career OpportunityWe're seeking a Compliance Officer to join our talented team in Belfast.The ideal candidate will have proven experience in a compliance or regulatory role, expertise in compliance laws, including AML, data protection, and anti-bribery regulations.Salary: £40,000 - £50,000 per annumYou will be part of a growing organisation that takes...
-
Co-op Regulatory Affairs
6 months ago
Belfast, United Kingdom Stryker Full timeJob Title Regulatory Affairs Co-Op Reports To Associate Manager, Regulatory Affairs Position Summary **This is a one-year placement student opportunity.** Key Areas of Responsibility - Help develop and maintain all Sales Bills of Materials to ensure consistency for customer orders. - Assist in preparation and development of new technical documents,...
-
Global Compliance Solutions Lead
1 day ago
Belfast, United Kingdom ARC Regulatory Ltd Full timeAbout UsARC Regulatory Ltd is a leading provider of compliance solutions to the pharmaceutical and biotechnology industries. Our team of experts has extensive experience in regulatory affairs, quality assurance, and clinical operations, and we are dedicated to helping our clients navigate the complex regulatory landscape.We are seeking a highly experienced...
-
Medical Device Specialist
2 weeks ago
Belfast, United Kingdom ARC Regulatory Ltd Full timeJob SummaryWe are looking for a skilled Medical Device Specialist to join our team at ARC Regulatory Ltd. As a Senior Specialist in Regulatory Affairs, you will be responsible for developing and implementing global regulatory strategies for IVD devices, ensuring compliance with key global markets.About YouYou have an engineering or scientific honours degree...
-
Clinical Research Coordinator
22 hours ago
Belfast, United Kingdom HIRANI Full timeClinical Research Coordinator - Senior Regulatory AffairsHirani is seeking a Senior Clinical Research Coordinator to provide high-level support to the company's senior management team. As a subject matter expert in clinical research coordination, you will ensure that all projects are managed efficiently and effectively, meeting client expectations and...
-
Regulatory Affairs Officer
4 weeks ago
Belfast, United Kingdom HAYS Specialist Recruitment Full timeJob DescriptionWe are looking for a highly experienced Regulatory Affairs Officer to join our team in enhancing public health and safety through effective regulation and engagement.As a key member of our project, you will be responsible for policy development, public consultation, and engagement with industry experts. Your responsibilities will include...
-
Regulatory Affairs Professional
22 hours ago
Belfast, United Kingdom 3173 Group Full timeAbout UsWe are a fast-growing company with a passion for innovation and customer satisfaction. Our team is dedicated to delivering high-quality solutions that meet the evolving needs of our clients.We operate in a dynamic and challenging environment, offering opportunities for growth and development.Job Description:We are seeking a skilled Compliance Officer...
-
Director of Regulatory Affairs
1 day ago
Belfast, United Kingdom Utility Regulator Full timeProtecting Consumers and Ensuring a Reliable Energy SupplyThe Utility Regulator is seeking a highly skilled Head of Legal to support our mission of safeguarding Northern Ireland's energy and water consumers. As a key member of our Senior Leadership Team, you will lead a team of legal advisors in providing expert guidance on regulatory, governance, and...