Regulatory Affairs Specialist

12 hours ago


Cardiff, Cardiff, United Kingdom yolk recruitment Full time
Regulatory Affairs Specialist Opportunity

Yolk Recruitment is partnering with a pioneering medical device business to find a talented Regulatory Affairs Specialist to join their team.

This is an exciting opportunity to be part of a high-growth, innovative business in a rewarding field. As a Regulatory Affairs Specialist, you will play a key role in providing guidance on regulatory affairs and supporting the development of new products.

Key Responsibilities:

  • Lead regulatory affairs activities and serve as the primary point of contact for compliance enquiries.
  • Work with colleagues across the business to ensure compliance with regulatory requirements.
  • Collaborate with NPD teams to review and approve documents, and participate in design and stage gate reviews.
  • Monitor new standards and ensure NPD meets recognized consensus standards.
  • Participate in CAPA teams to resolve issues and ensure continuous compliance.
  • Prepare and maintain technical files to meet regulatory requirements.
  • Develop and implement regulatory strategies for NPD and existing products.

Requirements:

  • Experience in Regulatory Affairs in the medical device industry.
  • Strong knowledge of regulatory requirements and standards.
  • Excellent communication and collaboration skills.
  • Ability to work in a fast-paced environment and prioritize tasks effectively.

This is a fantastic opportunity to join a dynamic team and contribute to the success of a pioneering medical device business.



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