Senior Manager/Director Regulatory Affairs

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

Senior Manager/Director, Regulatory Affairs

$175,000-$250,000

Job Description

EPM is partnered with a publicly traded commercial-stage medical device company that has developed a differentiated treatment for pulmonary and respiratory diseases and continues to expand its global footprint. The organization is seeking a Senior Manager or Director of Regulatory Affairs to play a key role in shaping regulatory strategy across a high-profile Class III product portfolio. This is an opportunity to join a collaborative leadership team where Regulatory Affairs has significant influence on product strategy, lifecycle management, and global expansion initiatives.

Key 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.
• Working knowledge of FDA regulations, guidance documents, and regulatory submissions.
• Experience collaborating cross-functionally with Quality, Clinical, R&D, and Marketing teams.
• Strong communication skills and ability to influence key stakeholders.
• Lead regulatory strategy and execution for new product development, product changes, and lifecycle management activities.
• Author, review, and support PMA supplements, regulatory submissions, and agency interactions.
• Partner with cross-functional teams to assess regulatory risks and develop strategic pathways to support business objectives.
• Serve as a key regulatory advisor during product development and commercialization activities.
• Monitor evolving regulatory requirements and assess potential impact on products and business strategy.
• Support global regulatory initiatives, registrations, and market expansion efforts.
• Represent Regulatory Affairs during cross-functional decision-making and leadership discussions.
• Competitive base salary and annual bonus opportunity
• Comprehensive medical, dental, and vision coverage