Director of Regulatory
About The Position
We are a rapidly growing, Boston-based medical technology company using AI to enable clinicians to make informed decisions on cardiovascular care - leading to better patient outcomes, improved quality of care, and reduced healthcare costs. Come work at Elucid and be part of delivering on our mission to prevent heart attacks and strokes! Every product we build has to earn its way to patient care, and regulatory strategy is how it gets there. We're looking for a Director of Regulatory who thrives on translating complex, evolving global requirements into clear paths to clearance for AI-enabled medical imaging software. You'll lead the execution of our regulatory strategy across FDA, EU MDR and other international markets, guiding submissions from pre-sub through post-market lifecycle management for a quickly growing startup. Partnering closely with our Quality, Engineering, Clinical, Commercial and Product teams, you'll sit at the center of how we bring innovative cardiovascular software safely and compliantly to the people who need it.
Requirements
- 7+ years of Regulatory Affairs experience in the medical device industry.
- Track record of successful submissions in the US and EU (pre-submissions, IDEs, 510(k)s, De Novo, EU MDR product registrations).
- Advanced degree in Regulatory Affairs, Life Sciences, Engineering, or a software-related discipline.
- 2-5+ years of people management experience.
- Strong cross-functional collaboration and communication skills.
- Expertise in global device regulatory requirements and standards (21 CFR Part 820, EU MDR, ISO 13485, ISO 14971, IEC 62304, IEC 62366).
- Experience in Software as a Medical Device (SaMD).
- Familiarity with FDA Class II devices and EU MDR Class IIa/IIb products preferred.
- Strong collaboration and communication skills, with the ability to translate complex regulatory requirements into actionable guidance and drive effective, cross-functional execution.
Nice To Haves
- Familiarity with FDA Class II devices and EU MDR Class IIa/IIb products
Responsibilities
- Lead the execution of our regulatory strategy across FDA, EU MDR and other international markets.
- Guide submissions from pre-sub through post-market lifecycle management.
- Translate complex, evolving global requirements into clear paths to clearance for AI-enabled medical imaging software.
- Partner closely with Quality, Engineering, Clinical, Commercial and Product teams.
Benefits
- Equal opportunity employer
- Value diversity
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What This Job Offers
Job Type
Full-time
Career Level
Director
