Director Regulatory Affairs
Director, Regulatory Affairs
USA (Remote)
$190,000 - $240,000
Job Description
EPM is partnered with an exciting, venture-backed neuromodulation company developing next-generation implantable technologies to treat neurological disorders and improve patient outcomes. With strong financial backing, a growing clinical pipeline, and several key milestones ahead, the company is seeking a Director of Regulatory Affairs to lead regulatory strategy and help drive products from development through commercialization. This is a high-visibility opportunity to shape the regulatory function within a rapidly growing organization developing truly transformative technology.
Key Qualifications
* Bachelor's degree in Engineering, Life Sciences, Regulatory Affairs, or related field; advanced degree preferred.
* 10+ years of Regulatory Affairs experience within the medical device industry.
* Strong experience with FDA submissions, including PMA, De Novo, and/or 510(k) pathways.
* Experience supporting implantable, Class III, or other high-risk medical devices preferred.
* Working knowledge of global regulatory requirements, including FDA and EU MDR.
* Proven ability to develop regulatory strategy across product development, clinical, and commercialization stages.
* Strong cross-functional leadership and stakeholder management skills.
* Experience building and scaling regulatory processes within a growing organization is highly desirable.
Roles & Responsibilities
* Lead global regulatory strategy for development, clinical, and commercial programs.
* Serve as the regulatory subject matter expert across R&D, Clinical, Quality, and Executive Leadership teams.
* Oversee regulatory submissions and interactions with FDA and other global health authorities.
* Provide strategic guidance on regulatory pathways, risks, and opportunities.
* Support clinical and product development activities to ensure regulatory alignment.
* Monitor evolving regulatory requirements and drive organizational compliance.
* Build and strengthen regulatory processes to support company growth and future product launches.
Benefits
* Comprehensive medical, dental, and vision coverage
* 401(k) with company contribution
* Competitive PTO and paid holidays
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.