Regulatory Affairs Professional for Medical Devices
2 days ago
Job Title: Regulatory Affairs Professional for Medical Devices
Location: Flexible working arrangements (remote/hybrid)
Estimated Salary: £85,000 - £105,000 per annum
About the RoleWe are seeking a highly experienced Regulatory Affairs professional to join our international team at G&L Healthcare Advisors. As a key member of our team, you will be responsible for providing expert guidance and support across a variety of medical devices and combination products.
You will work closely with our clients, guiding them through complex regulatory strategies and ensuring compliance with global regulations. This is an exciting opportunity for someone who thrives on challenges and enjoys client interaction.
Your day-to-day tasks may include leading regulatory strategy and submission processes, supporting the development of companion diagnostic projects, and advising clients on regulatory requirements for Laboratory Information Management Systems (LIMS).
Responsibilities- Lead regulatory strategy and submission processes for medical devices and combination products, ensuring compliance with MDR, IVDR, and other relevant regulations.
- Support the development of companion diagnostic projects, providing regulatory expertise from early stages through to product launch.
- Advise clients on LIMS regulatory requirements, ensuring data integrity and system validation align with current regulations.
- Prepare and submit regulatory dossiers for combination products that incorporate both medical devices and pharmaceuticals.
- Ensure compliance with global regulatory frameworks, including FDA, EMA, and other international markets.
- Provide guidance on post-market surveillance and risk management requirements for medical devices.
- Collaborate with cross-functional teams to provide strategic regulatory input.
- Minimum 5 years of experience in Regulatory Affairs, specifically in the medical device industry.
- Demonstrable experience of FDA submissions, including pre-submissions, IDE, 510(k), PMA, Technical Files/Design Dossier.
- Extensive knowledge of MDD, MDR, Med Dev's, FDA QSR's, ISO 13485 & 14155, and other applicable major/regional worldwide regulations.
- Experience with combination products and companion diagnostics.
- Understanding of LIMS regulatory requirements and validation processes.
- Familiarity with regulatory compliance for various medical device types (Class I, II, III).
- Excellent project management skills and ability to juggle multiple projects with competing priorities.
- Cutting-edge medical device projects across diverse fields.
- Collaborative and innovative environment with opportunities for professional growth.
- A competitive salary package.
- Flexible working arrangements.
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