Regulatory Director - Complex Software/electronic medical devices

Regulatory Director - Complex Software/Electronic Medical Devices

Location: North London

Job Role: This Regulatory Affairs Director role reports to the VP of RA/QA with the primary goal of supporting the international registration program with the new products they have coming to market.

This is very much a hands-on role with a team leadership mix - our client needs someone who can lead from the front, taking an active role in assisting in the execution of submissions for complex medical device submissions in China, Russia, Japan, EU, US, Canada, Latin America and other markets.

In order to fulfill this RA Director role, there is a requirement for overseas travel to meet regulatory authorities and local agents, to develop and execute strategy, to supervise testing (EMC or performance) and to negotiate with the relevant authorities.

Responsibilities:

1. Manage existing regulatory affairs managers and staff.
2. Lead the execution of submissions for complex medical device registrations.
3. Oversee product integration and medical device testing.
4. Travel internationally to meet with regulatory authorities.

Minimum Requirements:

1. Degree level education within a relevant science/engineering discipline.
2. Proven experience within a team management role (ideally 2 or more years).
3. Experience with active medical devices (software/electronic, IEC 60601 IEC 62304).
4. Solid experience within medical device regulatory affairs.
5. Direct experience of device testing.
6. Experience of interacting with regulatory bodies.
7. Proven experience of successful submission of complex Class IIb/III active medical devices in China or Russia.
8. Strong interpersonal skills including excellent communication, presentation and influencing skills.

Job Reference: J10022

Indo Professionals is a specialist staffing business dedicated to the medical technology market. We focus solely on placing professionals within quality, regulatory and clinical research teams.