Regulatory Affairs Strategy Lead (Medtech)

TL;DR

Regulatory Affairs Strategy Lead (Medtech): Developing and executing regulatory strategies for complex IVD systems and medical devices with an accent on US FDA, EU, and Japan registrations. Focus on managing high-stakes regulatory submissions, ensuring global compliance of labeling and promotional materials, and leading cross-functional teams to optimize registration processes.

Location: Remote (US)

Salary: $146,100 – $182,600 USD

Company

Global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health.

What you will do

• Develop and execute regulatory strategies for IVD systems, including hardware, software, and reagents.
• Coordinate and prepare complex submissions such as EU/IVD Technical Documentation, 510(k) premarket notifications, and NYS DoH submissions.
• Interact with regulatory authorities regarding pathways, performance claims, and labeling.
• Evaluate product changes for global regulatory impact and ensure compliance of promotional materials.
• Lead cross-functional teams to address process improvements and major regulatory initiatives.
• Mentor regulatory associates and deliver specialized training on regulatory topics.

Requirements

• Bachelor’s degree in life science (biology, chemistry, engineering, medical technology, etc.) or equivalent.
• Minimum of 12 years of direct applicable regulatory experience in medical devices.
• Working knowledge of U.S. and EU Medical Device/IVD regulatory requirements.
• Must be based in the United States.
• Ability to handle PHI and complete HIPAA/PHI privacy and security training.

Nice to have

• Advanced degree in life sciences (MS, PhD) or an MBA.
• RAC certification.
• Minimum of 5 years of managerial experience.
• Experience with IVD, CDx, or PMA submissions.

Culture & Benefits

• Comprehensive medical, dental, vision, life, and disability plans for employees and dependents.
• Free genetic testing for employees and their immediate families.
• Fertility care benefits and pregnancy/baby bonding leave.
• 401k and commuter benefits.
• Work in a high-growth environment alongside industry elite in genetic disease management.