Regulatory Affairs Specialist

5 days ago


Cardiff, Cardiff, United Kingdom Yolk Recruitment Ltd Full time

Job Summary

Yolk Recruitment Ltd is partnering with a pioneering medical device business to fill a new opportunity for a Regulatory Specialist to join their team.

This is a high-growth, high-innovation business in a rewarding field, offering the chance to make a mark in a lead role providing guidance on a wide range of regulatory affairs.

Key Responsibilities

  • Lead regulatory affairs activities and serve as the primary point of contact for compliance enquiries.
  • Collaborate with colleagues across the business, including R&D, Legal, Sales, and Operations.
  • 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 new product development and existing products.

Requirements

  • Experience in Regulatory Affairs in Class 1/+ medical devices for territories including FDA, UKCA, and MDR.
  • Knowledge of ISO13485, ISO14791, and maintenance of the risk management framework.
  • Proficiency in preparing submissions and communicating with regulatory organizations.
  • Ability to develop and implement regulatory strategies for new product development and existing products.
  • BEng/BSc in Engineering or Science with RA experience in the medical device industry.

What We Offer

  • Competitive salary, increasing through annual statutory and performance review.
  • Flexible benefits package.
  • Free on-site parking.
  • 25 days annual leave plus public holidays.
  • Employee Assistance Programme for you and your immediate family.
  • Training and Career Development Opportunities.


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