Regulatory Affairs Specialist
1 day ago
Yolk Recruitment Ltd is partnering with a pioneering medical device business to fill a new opportunity for a Regulatory Affairs Specialist to join their team.
This role offers the chance to be part of a high-growth, high-innovation business in a rewarding field, providing guidance on a wide range of regulatory affairs. You'll support NPD projects, ensuring product compliance and supporting audits, developing RA strategies to govern the continued development of existing products as well as new product development.
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 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 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.
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Cardiff, Cardiff, United Kingdom Yolk Recruitment Ltd Full timeYolk Recruitment Ltd is partnering with a pioneering medical device business to fill a Regulatory Specialist role. This is a high-growth opportunity to make your mark in a lead role providing guidance on regulatory affairs. You'll support new product development projects, ensuring product compliance and supporting audits. Your responsibilities will include...
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Cardiff, Cardiff, United Kingdom Yolk Recruitment Full timeJob Title: Regulatory Affairs SpecialistYolk Recruitment is partnering with a pioneering medical device business to fill a new opportunity for a Regulatory Specialist to join their team.This role offers the chance to be part of a high-growth, high-innovation business in a rewarding field, with the opportunity to make a significant impact in a lead role...
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Cardiff, Cardiff, United Kingdom Yolk Recruitment Full timeJob Title: Regulatory Affairs SpecialistYolk Recruitment is partnering with a pioneering medical device business to fill a new opportunity for a Regulatory Specialist to join their team.This role offers the chance to be part of a high-growth, high-innovation business in a rewarding field, with the opportunity to make a significant impact in a lead role...
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