Senior Regulatory Leader, Medical Devices (Class III PMA)

EPM Scientific; San Francisco (CA); On-site; USD 175,000 - 250,000; Full time

Job summary

EPM Scientific is partnering with a publicly traded medical device company in San Francisco to hire a Senior Manager or Director of Regulatory Affairs. You will shape regulatory strategy for a high-profile Class III portfolio, oversee PMA submissions, and collaborate with Quality, Clinical, R&D, and Marketing to influence product strategy and lifecycle management.

This senior leadership role requires 8+ years in Regulatory Affairs within medical devices, strong FDA knowledge, and a track record

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Regulatory Affairs, or a related field; advanced degree preferred.
• 8+ years of Regulatory Affairs experience within the medical device industry.
• Strong Class III and PMA experience required.
• Experience developing and executing regulatory strategies for complex medical devices.
• Prior experience with implantable, catheter-based, cardiovascular, structural heart, pulmonary, or other highly regulated medical device technologies preferred.

Skills

Regulatory strategy

PMA submissions

FDA regulations

Cross-functional leadership

Product life cycle management

Regulatory submissions

Global regulatory affairs

Stakeholder influence

Regulatory risk assessment

Education

Bachelor's degree in Engineering/Life Sciences/Regulatory Affairs

Advanced degree preferred

Job description

EPM Scientific is partnering with a publicly traded medical device company in San Francisco to hire a Senior Manager or Director of Regulatory Affairs. You will shape regulatory strategy for a high-profile Class III portfolio, oversee PMA submissions, and collaborate with Quality, Clinical, R&D, and Marketing to influence product strategy and lifecycle management.

This senior leadership role requires 8+ years in Regulatory Affairs within medical devices, strong FDA knowledge, and a track record