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
FAQs
Congratulations, we understand that taking the time to apply is a big step. When you apply, your details go directly to the consultant who is sourcing talent. Due to demand, we may not get back to all applicants that have applied. However, we always keep your CV and details on file so when we see similar roles or see skillsets that drive growth in organisations, we will always reach out to discuss opportunities.
Yes. Even if this role isn’t a perfect match, applying allows us to understand your expertise and ambitions, ensuring you're on our radar for the right opportunity when it arises.
We also work in several ways, firstly we advertise our roles available on our site, however, often due to confidentiality we may not post all. We also work with clients who are more focused on skills and understanding what is required to future-proof their business.
That's why we recommend registering your CV so you can be considered for roles that have yet to be created.
Yes, we help with CV and interview preparation. From customised support on how to optimise your CV to interview preparation and compensation negotiations, we advocate for you throughout your next career move.