Regulatory Affairs Specialist

4 weeks ago


Cardiff, Cardiff, United Kingdom Yolk Recruitment Ltd Full time

Yolk Recruitment Ltd is seeking a highly skilled Regulatory Affairs Specialist to join a pioneering medical device business during an exciting period of sustained expansion.

The successful candidate will support NPD projects, guiding others to ensure product compliance and support audits, developing RA strategies to govern the continued development of existing products as well as new product development.

This role offers the opportunity to be part of a high growth, high innovation business in a rewarding field, making your 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.
  • Work with colleagues throughout the business: R&D, Legal, Sales and Operation.
  • 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 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 NPD 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.
  • Matched 5% pension.
  • 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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