Regulatory Affairs Specialist
- Pre and Post Market matters within a global medical device organisation
- Cheshire Location, with flexibility on remote working
- Competitive Salary, Bonus, Expert Training, Flexible Work Arrangements
About the company
SRG partner with a Global Medical Technology Leader, home to a broad portfolio of critical care devices. As Regulatory Affairs Specialist, you will join a highly supportive team, approaching a period of growth within their sector.
- Ensure all regulatory compliance for medical devices products are maintained
- Prepare and update Technical Files to MDD/MDR requirements and ensure regulatory compliance for medical devices are maintained
- Review and load new product listings, product delisting, registration of new manufacturing sites, etc. into the registration and listing databases.
- Maintain renewals and the up to date information for all appropriate registration and listings databases.
- Complete inquiries and requests from internal and external sources in regard to import/export processes and practices and customs holds.
- Maintain security for all regulatory paper and electronic files.
- Develop, write, implement and maintain RA procedures.
- Complete regional RA requests and provide the requested documents i.e. CFG's, LOA's, documentation, etc.
- Review, comment and approve/disapprove change control requests which affect the marketing of medical devices.
- Complete a Letter to File following all US FDA regulations and guidance's.
- Review and approve/disapprove labeling change request, advertising and promotional request, field communications, etc. in accordance with standards and procedures and labeling regulations and guidance's.
- Execute, manage and close post market activities i.e. recalls and corrections. Prepare and submit all reporting activities associated with a removal or correction with US FDA and associated OUS Competent Authorities and Regional RA team's requirements.
- Keep informed about new and revised regulatory requirements.
Skills and Experience
- Regulatory/Quality experience within the medical device arena
- New Product development experience for medical devices
- Experience of creating documentation compliant with FDA CFR 820 and EC Medical Devices Directive 93/42/EEC
- Experience with US 510K would be preferable
Please contact me: Holly.Evans@srgtalent.com or +447909 207 693 for a confidential discussion around your career in Regulatory Affairs/Quality Assurance within the Med Tech arena.
your application has been submitted