Regulatory Affairs Specialist
2 days 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.
The role offers a 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.
This is what you'll be doing:
- Lead regulatory affairs activities and serve as the primary point of contact for compliance enquiries.
- Collaborate with NPD teams, reviewing and approving documents, and participating in design and stage gate reviews.
- Monitor new standards and 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.
And here's what you'll need:
- 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.
And this is what you'll get in return:
- 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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