Senior Regulatory Affairs Lead — Remote (Medical Devices)

Lexington Medical, Inc; United States; Remote; USD 115,000 - 185,000; Full time

Job summary

A medical device company is seeking a Senior Regulatory Affairs Specialist to lead regulatory submissions and strategy for new product development. This role offers flexibility in levels and can be remote, aligned with US East Coast hours. Candidates should have a Bachelor’s degree and extensive experience in medical device regulatory affairs. The position plays a crucial role in advancing the company's product pipeline and requires effective communication with cross-functional teams and regulatory authorities. Salary ranges from $115,000 to $185,000.

Qualifications

• 5–15+ years of experience in medical device regulatory affairs.
• Demonstrated ownership of FDA submissions and EU technical documentation.
• Experience with complex medical devices including electromechanical systems.

Responsibilities

• Lead and author regulatory submissions for U.S. and international markets.
• Own regulatory strategy and execution for new product development programs.
• Serve as the regulatory representative on cross‑functional product development teams.

Skills

Ownership of FDA submissions

Post-market surveillance

Communication skills

Attention to detail

Ability to manage multiple priorities

Education

Bachelor’s degree in Engineering, Science, Regulatory Affairs

Tools

ISO 13485

ISO 14971

EU MDR

Job description

A medical device company is seeking a Senior Regulatory Affairs Specialist to lead regulatory submissions and strategy for new product development. This role offers flexibility in levels and can be remote, aligned with US East Coast hours. Candidates should have a Bachelor’s degree and extensive experience in medical device regulatory affairs. The position plays a crucial role in advancing the company's product pipeline and requires effective communication with cross-functional teams and regulatory authorities. Salary ranges from $115,000 to $185,000.