Job Title: Senior Regulatory Affairs Associate
Location: West Yorkshire - some flexible remote
Competitive Salary + Benefits
Are you an experienced Regulatory Affairs professional with a solid understanding of EU MDR and global medical device regulations? We are recruiting a Senior Regulatory Affairs Associate to join a forward-thinking medical device organization. This role is essential in ensuring regulatory compliance across the product lifecycle, supporting market expansion, and driving successful regulatory submissions and approvals.
The ideal candidate will bring technical expertise, attention to detail, and the ability to collaborate with cross-functional teams to maintain compliance and support product innovation.
Key Responsibilities:
1. Regulatory Submissions: Prepare and submit regulatory documentation for new products, modifications, and renewals, including CE Marking, 510(k), PMA, and international submissions.
2. Regulatory Strategy: Develop and implement strategies for timely approvals, aligning with both U.S. and international requirements.
3. Regulatory Compliance: Maintain compliance with medical device regulations, standards, and guidance documents throughout the product lifecycle. Stay updated on emerging regulatory changes and communicate key impacts.
4. Qu...