Are you an experienced regulatory professional looking for your next long-term career move? You will need SaMD and FDA experience for this one!!
100% remote.
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!