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About the Role

Drive global regulatory strategy and submissions for AI-driven medical products, serving as a regulatory subject matter expert across SaMD, AI/ML algorithms, and mobile medical apps. Partner closely with cross-functional teams from agile planning through global commercial clearance and post-market activities.

Responsibilities

Represent Regulatory Affairs on cross-functional teams to ensure regulatory alignment and generation of submission deliverables.
Author and execute global regulatory strategies including FDA Pre-submissions, 510(k)s, De Novo requests, and EU MDR CE Marking.
Develop submission strategies for advanced digital health technologies, including AI/ML-enabled devices, GMLP, and PCCPs.
Develop relationships and lead communications with regulatory agencies and third-party business partners.
Maintain regulatory pre-market and post-market commitments and compliance.
Evaluate software changes to determine necessary filings versus internal documentation.
Track evolving digital health policies and provide guidance to internal teams.
Provide guidance and training to team members on medical device software development and regulations.

Requirements

Bachelor’s Degree in Computer Science (ML/AI), Biomedical Engineering, Software Engineering, Electrical Engineering, or a related scientific field.
10+ years of direct Regulatory Affairs experience in medical devices, with at least 4+ years explicitly focused on SaMD, SiMD, or complex digital health solutions including deep knowledge in AI/ML.
6+ years of experience with a Master’s degree; or 4+ years with a PhD.
Direct experience successfully clearing or approving SaMD applications (e.g., 510(k), De Novo, or CE Mark) with FDA and/or EU Notified Bodies.
Knowledge of software-specific standards and frameworks: IEC 62304, ISO 14971, IEC 82304-1.
Able to clearly work towards established goals and initiatives with minimal oversight.
Strong ability to translate complex software engineering language into clear regulatory rationale for health authorities.
Excellent communication skills (written, verbal, editing).
Proven track record working effectively within software development environments.
Strong organizational, leadership, interpersonal and influencing skills.
Direct experience submitting Predetermined Change Control Plans (PCCPs) for AI/ML algorithms.
Knowledge of clinical trial strategy and clinical study design.

Skills

SaMD
AI/ML
Mobile medical apps
FDA Pre-submissions
510(k)s
De Novo requests
EU MDR CE Marking
Good Machine Learning Practice (GMLP)
Predetermined Change Control Plans (PCCPs)
IEC 62304
ISO 14971
IEC 82304-1
Regulatory intelligence
Communication
Leadership
Organizational skills
Interpersonal skills
Influencing skills

Location

US
UK
Europe
Japan
Canada

Work Type

Full-time

Experience Level

Principal
10+ years
4+ years (AI/ML focus)
6+ years (Master's)
4+ years (PhD)

Education Level

Bachelor’s Degree
Master’s degree
PhD

Salary/Compensations

$188,000 - $240,000

Benefits

Bonus
Equity

About the Company

Heartflow is a medical technology company advancing the diagnosis and management of coronary artery disease using AI-driven, non-invasive cardiac testing.
The flagship product, Heartflow FFRCT Analysis, provides a 3D model indicating the impact of blockages on blood flow to the heart.
Heartflow is the first AI-driven non-invasive integrated heart care solution across the CCTA pathway.
Heartflow is a publicly traded company (HTFL) recognized for healthcare innovation.
The product is cleared for use in the US, UK, Europe, Japan, and Canada and has been used for over 750,000 patients worldwide.

Equal Opportunity

Heartflow is an Equal Opportunity Employer.
We are committed to a work environment that supports, inspires, and respects all individuals.
We do not discriminate against any employee or applicant because of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.
This policy applies to every aspect of employment at Heartflow, including recruitment, hiring, training, relocation, promotion, and termination.