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