Regulatory Affairs Specialist
2 weeks ago
Job Overview
At Hunter Selection, we are seeking an experienced Regulatory Affairs professional to join our team. As a Senior Regulatory Specialist, you will play a key role in designing and implementing Quality Management Systems for design control, ensuring continuous compliance with regulatory requirements.
Responsibilities
- Develop and implement regulatory strategies for new product development and existing products to maintain compliance with international regulatory standards.
- Prepare and submit regulatory applications to international regulatory approvals, ensuring timely and accurate compliance.
- Lead RA activities and serve as the first point of contact for compliance enquiries, providing expert guidance and support.
- Manage day-to-day activities and tasks, working independently in RA matters to ensure seamless operations.
Requirements
- Medical Device experience is essential for this role, with a proven track record of regulatory compliance and submission.
- Class 2A/B medical device experience is required, with a strong understanding of regulatory application knowledge.
What We Offer
- Highly competitive salary and bonus opportunity.
- 25 days + bank holidays, employee assistance program, and matched 5% pension.
- Funded company social events, free on-site parking, and secure cycle shelter.
- Discounts at local restaurants and gyms.
About Us
Hunter Selection is a recruitment consultancy with UK-wide offices, specialising in permanent and contract roles within Engineering & Manufacturing, IT & Digital, Science & Technology, and Service & Sales sectors.
We are proud to support a rapidly growing organisation with exciting plans to increase headcount on site due to increased market share and orders.
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