Director Regulatory Affairs

Director Regulatory Affairs

Salary: ($220,000-$250,000)

San Francisco Bay Area (hybrid)

EPM is partnered with a medical device company making waves in the heart valve space. This pre-IPO organizaiton is rapidly growing and is seeking a Director Regulatory Affairs to lead the RA team. The leadership team has attracted strong investment resulting in significant funding in the last two years. This is a high exposure role to the senior executive team, and is a great opportunity to take part in helping the lives of patients, worldwide.

Responsibilities:

• Lead global regulatory strategy and submissions for Class III cardiovascular devices
• Collaborate cross-functionally with R&D, Clinical, and Quality teams to align regulatory pathways
• Represent the company in meetings with FDA, Notified Bodies, and other global regulatory agencies
• Monitor evolving regulations and proactively adapt strategies to maintain compliance and market access.

The ideal candidate for this role will have:

• Bachelor's degree in life sciences or Biomedical Engineering (advanced degree preferred)
• 10+ years of regulatory affairs experience in the medical device industry, with a focus on cardiovascular products
• Proven track record of successful PMA, CE Mark, and international submissions
• Strong leadership, communication, and strategic thinking skills

This company offers a competitive compensation package:

• Annual bonus
• Equity package
• Insurance
• Etc