Regulatory Affairs Specialist

Are you an experienced regulatory professional looking for your next long-term career move?

I am partnering with an innovative, medical technology business to find a dedicated Regulatory Affairs Specialist to join their growing RAQA team on a permanent & 100% remote basis!

In this pivotal role, you will champion global regulatory compliance, drive regulatory strategy, and ensure seamless market access for cutting-edge products across multiple regions.

What You Will Be Doing:

• Leading and managing critical regulatory submissions, with a primary focus on EU MDR technical files and FDA 510(k).
• Acting as the Person Responsible for Regulatory Compliance (PRRC) when required.
• Producing and maintaining essential clinical (CEP, CER) and post-market surveillance (PMSP, PSUR) documentation.
• Guiding cross-functional Product and Engineering teams to embed regulatory requirements directly into the product development lifecycle.
• Managing vigilance activities and driving new regional product registrations.

What You Bring to the Table:

• A solid regulatory affairs background within the medical device sector.
• Proven, hands-on success with EU MDR and FDA 510(k) submissions.
• Deep working knowledge of ISO 13485:2016, MDSAP, ISO 14971, IEC 62304, and ISO 62366-1.
• A relevant degree in Life Sciences, Biomedical Engineering, Computer Science, or RA.
• Direct experience with Software as a Medical Device (SaMD) and an understanding of medical imaging modalities!

If you are ready to take ownership of global regulatory strategies in a forward-thinking, collaborative environment, let’s talk!

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