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- Tasks: Lead regulatory submissions for complex medical devices across global markets.
- Company: Indo Professionals specializes in staffing for the medical technology sector.
- Benefits: Opportunity for international travel and hands-on leadership experience.
- Why this job: Join a dynamic team making an impact in medical technology with global reach.
- Qualifications: Degree in science/engineering and 2+ years in team management required.
- Other info: Experience with active medical devices and regulatory bodies is essential.
The predicted salary is between 72000 - 108000 £ per year.
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:
- Manage existing regulatory affairs managers and staff.
- Lead the execution of submissions for complex medical device registrations.
- Oversee product integration and medical device testing.
- Travel internationally to meet 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).
- 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.
- Proven experience of successful submission of complex Class IIb/III active medical devices in China or Russia.
- 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.
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Regulatory Director - Complex Software/electronic medical devices employer: Frey Consulting Group
Contact Detail:
Frey Consulting Group Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Director - Complex Software/electronic medical devices
✨Tip Number 1
Make sure to highlight your experience with complex medical devices, especially in relation to IEC 60601 and IEC 62304 standards. This will show that you have the technical knowledge required for the role.
✨Tip Number 2
Demonstrate your leadership skills by providing examples of how you've successfully managed teams in previous roles. This is crucial since the position requires managing existing regulatory affairs managers and staff.
✨Tip Number 3
Prepare to discuss your international experience with regulatory submissions, particularly in markets like China and Russia. Being able to share specific examples will set you apart from other candidates.
✨Tip Number 4
Showcase your strong interpersonal skills by preparing to discuss how you've effectively communicated and negotiated with regulatory bodies in the past. This is key for building relationships in this role.
We think you need these skills to ace Regulatory Director - Complex Software/electronic medical devices
Some tips for your application 🫡
Understand the Role: Make sure to thoroughly understand the responsibilities and requirements of the Regulatory Director position. Highlight your relevant experience in regulatory affairs, especially with complex medical devices.
Tailor Your CV: Customize your CV to emphasize your experience with active medical devices, team management, and successful submissions in various international markets. Use specific examples that demonstrate your leadership and technical skills.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for regulatory affairs and your ability to lead teams. Mention your experience with regulatory bodies and your success in navigating complex submissions, particularly in China and Russia.
Highlight International Experience: Since the role requires overseas travel, be sure to mention any previous international experience you have, especially related to meeting with regulatory authorities or managing submissions in different countries.
How to prepare for a job interview at Frey Consulting Group
✨Show Your Leadership Skills
As a Regulatory Director, you'll need to demonstrate your ability to lead a team effectively. Prepare examples of how you've successfully managed teams in the past, especially in high-pressure situations related to regulatory submissions.
✨Highlight Your Technical Expertise
Make sure to discuss your experience with active medical devices and relevant standards like IEC 60601 and IEC 62304. Be ready to explain complex concepts in a way that shows your deep understanding of regulatory affairs.
✨Prepare for International Regulations
Since the role involves international travel and interaction with various regulatory bodies, familiarize yourself with the specific requirements for markets like China, Russia, and the EU. This knowledge will show your preparedness for the role.
✨Demonstrate Strong Communication Skills
Effective communication is key in this role. Practice articulating your thoughts clearly and confidently, as you will need to influence and negotiate with regulatory authorities. Consider role-playing scenarios to enhance your presentation skills.
