Regulatory Affairs Specialist
My client, a leading regulatory consultancy based in Yorkshire, is expanding and looking to recruit a medical devices Regulatory Affairs professional on a permanent basis. The role will be based on-site.
Responsibilities:
1. Responsible for compliance and diligence of product technical files.
2. Provide and support advice and technical updates in Medical Device Regulations (MDR) – Class 2 & 3.
3. Liaise with regulated bodies – submissions, queries, and clarity.
4. Compile and control product technical files for all new MDR product registrations.
5. Review compliance and update existing product technical files.
6. Experience in Post Market Surveillance (PMS), collation, review, and writing.
7. Provide input and support to site leadership and business direction.
Qualifications:
1. Proven experience in the regulated environment of the medical devices industry in QA, Quality Assurance, and RA Regulatory Affairs.
2. Previous industrial experience of MDR, regulatory submission, project management, quality supplier auditing, and Quality systems (QMS).
3. Knowledge/experience of relevant legislation MDR.
4. A degree in life science, STEM, or related subject.
If you believe you hold the relevant background experience and are looking for a new role as RA Specialist within this independent, successful, and growing business, then this is the role for you.
About us: Templarfox is a privately owned recruitment business leading in executive search, management selection, salary benchmarking, and business development services. The recruiter has stated that all applicants for this job should be able to prove that they are legally entitled to work in the UK, and on this occasion, TemplarFox Consultancy is acting as an employment agency.
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