Director / Senior Regulatory Affairs Leader (US)

Director, Regulatory Affairs (US)

We are seeking an experienced Regulatory Affairs leader to establish and lead the US regulatory function for a growing medical device company. This individual will be responsible for FDA engagement, regulatory submissions, compliance strategy, and supporting market expansion across the US.

Responsibilities

• Build and lead the US Regulatory Affairs function, including SOPs, processes, and regulatory infrastructure.
• Serve as the primary contact with the FDA and lead regulatory submissions, including 510(k), De Novo, and PMA pathways.
• Develop and execute regulatory strategies supporting product development, commercialization, and lifecycle management.
• Serve as US Agent, Initial Importer, and Medical Device Distributor.
• Manage post-market regulatory activities and ongoing compliance requirements.
• Partner with Quality, Clinical, Product Development, Engineering, and Commercial teams.
• Support US market expansion and contribute to global regulatory strategy.

Qualifications

• Bachelor's degree in a scientific, engineering, healthcare, or related field.
• 8+ years of medical device Regulatory Affairs experience, including at least 5 years supporting FDA-regulated products.
• Proven experience leading FDA submissions and obtaining regulatory clearances or approvals.
• Strong FDA engagement experience, including pre-submission and submission meetings.
• Experience building regulatory processes, SOPs, systems, or teams in a startup, scale-up, or high-growth environment.
• Eligibility to serve as US Agent, Initial Importer, and Medical Device Distributor.
• Experience supporting market or clinical expansion initiatives.

Preferred

• Software as a Medical Device (SaMD) experience.
• Experience with both hardware and software medical devices.
• Experience building or scaling Regulatory Affairs teams.
• Familiarity with AI-enabled regulatory tools and workflow automation.

Compensation: $191,250 - $233,750 base salary, plus benefits and potential equity.