Regulatory Affairs Specialist

GXPeople Global Ltd.; United States; Remote; GBP 60,000 - 90,000; Full time

Job summary

GXPeople Global Ltd. is seeking an experienced Regulatory Affairs Specialist for a permanent, 100% remote role. You will drive regulatory strategy and global compliance to enable market access for cutting-edge devices, including SaMD, across regions.

You will manage EU MDR and FDA 510(k) submissions, create essential documentation, and guide cross-functional teams to integrate regulatory requirements into development. Experience with ISO standards and imaging modalities is preferred.

Qualifications

• Regulatory background in medical devices or SaMD.
• Proven submissions experience: EU MDR or FDA 510(k).
• Knowledge of ISO 13485:2016, MDSAP, ISO 14971, IEC 62304, ISO 62366-1.
• Degree in Life Sciences, Biomedical Engineering, Computer Science, or RA.
• Experience with SaMD and medical imaging modalities.

Responsibilities

• Lead/regulatory submissions focusing on EU MDR and FDA 510(k).
• Produce and maintain CEP, CER, PMSP, PSUR docs.
• Advise Product/Engineering on embedding regulatory in development lifecycles.
• Oversee vigilance activities and new regional registrations.

Skills

Regulatory affairs

Medical devices

EU MDR

FDA 510(k)

Regulatory submissions

Education

Life Sciences degree

Biomedical Engineering degree

Tools

eQMS systems

Job description

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).
• 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 or 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!