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.
Work Location:- 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.
Salary Range:- 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.
At Elucid, we believe the best work happens in a flexible hybrid environment. Boston-area employees are encouraged to work from the office on Mondays and Wednesdays, with the option to come in additional days if they prefer. Fully remote employees outside the Boston area come in as needed.
We understand that self-doubt can sometimes prevent great candidates from applying. If you believe you can make an impact at Elucid, even if you don't meet every qualification, we encourage you to apply!
