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.
The ideal candidate will have:
- 7+ years of Regulatory Affairs experience in the medical device industry, with a 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, with 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.
- This role is based out of our office in Boston, MA. For local candidates, we operate in a hybrid model with regular in-office collaboration. Candidates outside of the Boston area are invited to apply as fully-remote employees.
- The anticipated base salary range for this position at Elucid is $175,000-$225,000. Compensation will be influenced by a wide array of factors including but not limited to internal pay equity, job-related knowledge, skills, education, relevant experience, certifications, and geography as outlined in the job description.
Skills Required
- 7+ years of Regulatory Affairs experience in the medical device industry
- Successful US and EU regulatory submissions, including pre-submissions, IDEs, 510(k)s, De Novo applications, and EU MDR product registrations
- Advanced degree in Regulatory Affairs, Life Sciences, Engineering, or a software-related discipline
- 2-5+ years of people management experience
- Expertise in global medical device regulatory requirements and standards
- Experience with 21 CFR Part 820, EU MDR, ISO 13485, ISO 14971, IEC 62304, and IEC 62366
- Experience with Software as a Medical Device (SaMD)
- Familiarity with FDA Class II devices and EU MDR Class IIa/IIb products
- Strong cross-functional collaboration and communication skills
- Ability to translate complex regulatory requirements into actionable guidance and drive cross-functional execution
What We Do
Elucid is a Boston-based medical technology company using uniquely interpretable and validated AI to provide physicians with a cost-effective means to optimize treatment decisions for patients with cardiovascular disease. Advanced clinical insight from Elucid equips physicians with critical information designed to enable precision medicine. Elucid is the first FDA-Cleared and CE-marked non-invasive software to quantify atherosclerotic plaque characteristics compared to histopathology, including Lipid Rich Necrotic Core. The company has published studies for its derivation of fractional flow reserve (FFRct) based on the vasodilative capacity of the vessel wall and estimation of coding and non-coding RNA transcripts (“Virtual Transcriptomics”). This unique information informs improved treatment decisions by physicians leading to better patient outcomes, improved quality of care, and reduced healthcare costs. The Elucid software is available for commercial use in the U.S. and Europe
