Regulatory Affairs Director

4 weeks ago


Cheltenham, Gloucestershire, United Kingdom Selexa Biotech Full time
Senior Regulatory Affairs Professional

Selexa Biotech is seeking a highly experienced Senior Regulatory Affairs professional to lead our Regulatory Affairs team. As a key member of our organization, you will be responsible for ensuring compliance with regulatory requirements for our medical devices.

The ideal candidate will have a strong background in medical device regulatory affairs, with a minimum of 7-10 years of experience. You will be responsible for creating, updating, and maintaining technical files, as well as leading a team of Regulatory Affairs Specialists.

Key Responsibilities:

  • Develop and implement regulatory strategies for new products and design changes to existing products.
  • Ensure compliance with regulatory requirements, including ISO 13485, 14971, UKMDR, MDD 93/42/EEC, and MDR 2017/45.
  • Lead the creation and maintenance of Clinical Evaluation Reports and Technical Files.
  • Collaborate with cross-functional teams to ensure regulatory compliance throughout the product lifecycle.
  • Conduct internal audits and provide training to team members as needed.
  • Contribute to departmental and company objectives/KPIs.

Candidate Requirements:

  • A degree or relevant experience in Medical Devices, Engineering, or associated Scientific discipline.
  • Strong understanding of Quality Management Systems and regulatory requirements.
  • Excellent leadership and communication skills.
  • Ability to work in a fast-paced environment and prioritize multiple tasks.

Selexa Biotech is an equal opportunities employer and welcomes applications from all qualified candidates. Sponsorship is not available for this opportunity, and candidates must be based in the UK.



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