Regulatory Director - Complex Software / electronic medical devices

Frey Consulting Group; London; On-site; CAD 100,000 - 125,000; Full time

Job summary

A leading healthcare consultancy is seeking a Regulatory Director to manage a team and oversee complex medical device submissions. The successful candidate will have a strong background in medical device regulatory affairs and experience in international registration. This role involves direct interaction with regulatory authorities and requires overseas travel. Ideal for candidates with proven leadership in a relevant field.

Qualifications

• Proven experience in team management of at least 2 years.
• Experience with active medical devices and IEC standards.
• Direct experience of testing medical devices.

Responsibilities

• Manage regulatory affairs managers and staff.
• Support the international registration program for new products.
• Lead execution of submissions for complex medical devices.
• Oversee testing and negotiate with regulatory authorities.

Skills

Team management

Medical device regulatory affairs

Communication skills

Submission of Class IIb/III devices

Education

Degree in a relevant science/engineering discipline

Job description

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 fulfil 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 :

• Manage the existing regulatory affairs managers and regulatory affairs staff.
• Support the international registration program for new products.
• Lead the execution of submissions for complex medical devices.
• Oversee testing and negotiate with regulatory authorities.

Minimum Requirements :

Degree level education within a relevant science / engineering discipline.

Proven experience within a team management role – ideally 2 or more years, including leading local and international teams of at least 2 people.

Experience with active medical devices (software / electronic, IEC 60601, IEC 62304).

Solid experience within medical device regulatory affairs.

Direct experience of device testing.

Experience of interacting with regulatory bodies such as notified bodies.

Proven experience of successful submission of complex Class IIb / III active medical devices in China or Russia – essential.

Experience with liaising with legal counsel, regulatory bodies, and agencies.

Experience in Clinical Literature Evaluation (CER).

Strong interpersonal skills including excellent communication, presentation, and influencing skills.

Job Reference : J10022

J-18808-Ljbffr