Director of Regulatory

Elucid; Boston (MA); Hybrid; USD 175,000 - 225,000; Full time

Job summary

Elucid, a Boston-based medical technology company using AI for cardiovascular care, seeks a Director of Regulatory to lead global regulatory strategy for SaMD. You will drive submissions to FDA and EU MDR, manage lifecycle activities, and collaborate across Quality, Engineering, Clinical, Commercial and Product teams to bring safe, compliant solutions to clinicians.

The role sits in a hybrid Boston office with optional fully remote arrangements for non-Boston applicants, requiring 7+ years in

Qualifications

• 7+ years in Regulatory Affairs within medical devices with US/EU submissions.
• Advanced degree in Regulatory Affairs, Life Sciences, Engineering, or software discipline.
• 2–5+ years of people management and cross-functional leadership.
• Expertise in global regulatory requirements: 21 CFR Part 820, EU MDR, ISO 13485, ISO 14971, IEC 62304.
• Experience with SaMD and FDA Class II/equivalent EU classifications.

Responsibilities

• Lead regulatory strategy across FDA and EU MDR and other markets.
• Oversee submissions from pre-submission through post-market lifecycle.
• Partner with Quality, Engineering, Clinical, Commercial and Product teams.
• Translate complex requirements into actionable guidance and drive execution.

Skills

Regulatory leadership

FDA & EU submissions

Cross-functional collaboration

SaMD regulatory experience

Regulatory strategy

Regulatory standards knowledge

Education

Advanced degree in Regulatory Affairs

Job description

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.

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 are an equal opportunity employer and value diversity at Elucid. We do not discriminate based on race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability.