Regulatory Affairs Professional

3 weeks ago

Cardiff, Cardiff, United Kingdom Yolk Recruitment Ltd Full time
Regulatory Affairs Specialist Opportunity

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

This is an exciting opportunity to be part of a high-growth, high-innovation business in a rewarding field, with a focus on regulatory affairs. As a Regulatory Affairs Specialist, you will play a key role in ensuring the company's products comply with regulatory requirements, supporting new product development projects, and developing regulatory strategies to govern the continued development of existing products.

Key Responsibilities:
  • Lead regulatory affairs activities and serve as the primary point of contact for compliance enquiries.
  • Collaborate with cross-functional teams, including R&D, Legal, Sales, and Operations, to ensure regulatory compliance.
  • Review and approve documents, participate in design and stage gate reviews, and monitor new standards to 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 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.
  • Excellent communication skills to collaborate with cross-functional teams.
  • Proficient in managing day-to-day RA activities and tasks independently.
  • Positive and optimistic attitude, with a focus on customer and patient safety and usability.
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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