Regulatory Advisor

Fractional regulatory adviser | 2 days a month | Active medical device

Valtera Group is partnering with an early-stage medical device company to appoint an independent Regulatory Adviser. The company is developing an active electrical device and is working towards design freeze, ahead of FDA and further international submissions.

This is a focused advisory retainer, not a full-time role. It suits an experienced IEC 60601 specialist who wants a small, high-impact engagement alongside other work.

THE CONTEXT

The company has in-house QA/RA ownership and an FDA adviser already in place. It now wants an independent expert to guide, review and sense-check its regulatory and quality work, with practical advice that fits a lean team.

WHAT YOU'LL DO

• Confirm design inputs against IEC 60601-1 and relevant collateral and particular standards, plus software, usability, biocompatibility and battery standards
• Review the V&V plan and test strategy before testing begins
• Advise on usability and clinical study protocols, design and sample size
• Sense-check the ISO 14971 risk management file and benefit-risk reasoning
• Act as independent reviewer at key design reviews
• Carry out ISO 13485 internal audits ahead of certification
• Review technical documentation for completeness before FDA submission
• Be a regular sounding board for the leadership team

WHAT WE'RE LOOKING FOR

Essential:

• Deep, hands-on IEC 60601 experience with active electrical medical devices. This is the deciding criterion.

Strongly preferred, in priority order:

• FDA Class II submission experience, ideally 510(k)
• Depth in design control and V&V review
• ISO 14971 risk management and ISO 13485 internal auditing
• Experience advising on human factors and clinical studies

This is likely to suit you if you:

• Already work independently, or want to, and are looking for a small advisory retainer rather than a full-time RA role
• Have a background in a Notified Body, test house, engineering consultancy or independent RA/QA practice
• Communicate clearly and practically, and work well with a small, fast-moving team
• Can spend regular time on site in the South East

THE ENGAGEMENT

• Around 2 days a month, flexible and weighted towards design reviews and milestones
• Mostly remote, with regular time on site

Client details are shared at first conversation.

#J-18808-Ljbffr