Regulatory Affairs Specialist
1 day ago
Yolk Recruitment Ltd is partnering with a pioneering medical device business to find a 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, with 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.
- 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.
- 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
- State of the art premises, free parking
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Cardiff, Cardiff, United Kingdom yolk recruitment Full timeRegulatory Affairs Specialist OpportunityYolk 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...
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