Regulatory Affairs Specialist
1 month ago
Cure Talent is proud to be partnering with a leading MedTech manufacturer, specializing in innovative surgical products based in the heart of England.
We are seeking an experienced Regulatory Affairs Specialist to join their team due to exceptional growth. As the new Regulatory Affairs Specialist, you will work closely with the Head of Quality Assurance and Regulatory Affairs, collaborating with a well-established team of regulatory professionals. Your key responsibilities will include product registrations, post-market surveillance, customer complaints, and CAPA reporting.
To succeed in this role, we are looking for an experienced MedTech Regulatory Affairs professional with proven experience in maintaining and developing Technical Files under the Medical Device Regulation (MDR). Essential skills and qualifications include:
- Proven Regulatory Affairs experience within the Medical Device sector
- Broad background in quality and regulatory compliance of systems and products
- Broad background in electro/mechanical products, including an understanding of the impact of regulatory requirements
- Experience of medical standards and European/FDA regulations such as ISO 13485, EC 93/42, and MDR
- Additional desirable skills include Cybersecurity, AI/ML, HFE, Usability, Software Development, and/or Biocompatibility
Based on your expertise, the estimated annual salary for this position is £55,000 - £65,000.
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