Vice President of Clinical and Regulatory Affairs

Charlton Morris is supporting a cardiovascular medical device start-up that specializes in the treatment of structural heart disease. Our client is seeking a talented hands-on leader with deep experience in both clinical and regulatory affairs to join the team.

This start-up has sites in both the US and EU and is flexible on location to where candidates can be based, providing one is happy to travel (up to 50%). The preference is for US candidates to be based on the East Coast.

As the VP of Clinical & Regulatory Affairs, you will play a pivotal role in driving the development and launch of their innovative cardiovascular devices. You will lead the strategy, design and execution of clinical studies for a Class III implantable transcatheter valve replacement system. Your efforts will help obtain regulatory approvals and guide clinical research initiatives, ensuring that the devices meet the highest standards of safety, efficacy, and quality. This is a unique opportunity to shape the future of cardiovascular medicine and lead a talented team of professionals.

Requirements:

• At least 12 years of experience in clinical affairs with Class III medical devices
• Solid experience in obtaining regulatory approval with Class III medical devices (US & EU regulatory bodies)
• Proven track record of success working within the structural heart space (TAVR, TMVR, TTVR etc)
• Excellent relationships with Interventional Cardiologists and KOLs in US or EU
• Exceptional leadership and communication skills, with the ability to lead and inspire cross-functional teams
• Good relationships with key stakeholders at the FDA
• Willingness to travel (up to 50%)
• Strategic thinker

This start-up is extremely well-funded and has big plans for the future. To be considered for this opportunity, please email james.christopher@charltonmorris.com with your resume and a short note as to why you are the right candidate for this role.

Please note: I anticipate a high volume of applicants and I’m simply unable to respond to all. If you do not meet the above criteria and haven’t heard from me within 14 days of applying, please assume you have been unsuccessful.