Regulatory Specialist Remote, United States

HeartFlow, Inc.; United States; Remote; USD 90,000 - 105,000; Full time

Job summary

A leading medical technology company is seeking a Regulatory Affairs Specialist to join their Quality and Regulatory Affairs team. The role involves supporting software releases, managing regulatory documentation, and collaborating with cross-functional teams. The ideal candidate has 1-3 years of regulatory experience and strong communication skills. This position offers a competitive salary and the opportunity to work in a dynamic environment focused on advancing heart care.

Qualifications

• 1-3 years of experience in Regulatory Affairs.
• Software medical device experience a plus.

Responsibilities

• Support frequent minor software releases by performing change assessments.
• Manage timely completion of new product registrations.
• Conduct regulatory surveillance and communicate changes in regulations.

Skills

Project management

Team collaboration

Communication

Education

1-3 years of experience in Regulatory Affairs

Tools

Word

Excel

PowerPoint

Job description

Heartflow is a medical technology company advancing the diagnosis and management of coronary artery disease, the #1 cause of death worldwide, using cutting-edge technology. The flagship product—an AI-driven, non-invasive cardiac test supported by the ACC/AHA Chest Pain Guidelines called the Heartflow FFR CT Analysis—provides a color-coded, 3D model of a patient’s coronary arteries indicating the impact blockages have on blood flow to the heart. Heartflow is the first AI-driven non-invasive integrated heart care solution across the CCTA pathway that helps clinicians identify stenoses in the coronary arteries (RoadMapAnalysis), assess coronary blood flow (FFR CT Analysis), and characterize and quantify coronary atherosclerosis (Plaque Analysis).Our pipeline of products is growing and so is our team; join us in helping to revolutionize precision heartcare.

Heartflow is a VC-backed company that has received international recognition for exceptional strides in healthcare innovation, is supported by medical societies around the world, cleared for use in the US, UK, Europe, Japan and Canada, and has been used for more than 400,000 patients worldwide.

The Regulatory Affairs Specialist is part of the Quality and Regulatory Affairs team. The individual has 1-3 years of experience in Regulatory with an understanding of regulatory requirements and is able to resolve a wide-range of issues while maintaining compliance to regulations and standards. This individual will play a key role in HeartFlow regulatory activities involving cross-functional collaboration for product changes, as well as maintenance of key regulatory documentation. #LI-Remote; #LI-IB1

Job Responsibilities:

• Support frequent minor software releases by performing change assessments
• Support EU MDR application and maintenance of technical documentation, including clinical evaluation
• Collaborate with cross-functional teams to drive regulatory project management activities
• Manage timely completion of new product registrations and maintain global regulatory approvals to market software devices
• Collaborate with external partners including regulatory agencies, authorized representatives, importers and distributors
• Gain experience with US FDA submissions
• Provide input to the risk management process to ensure risks are identified and updated during the product life-cycle
• Conduct regulatory surveillance and communicate changes in regulations., standards, and guidances
• Support Quality System management, as needed
• Other relevant duties as assigned
• Ability to work in a fast-paced adaptive environment, self-starter, and strong team player

Skills Needed:

• Base knowledge of global regulatory requirements
• Project management skills a plus
• Demonstrated team collaboration
• Excellent communication, writing, and editing skills
• Strong Word, Excel, and PowerPoint skills

Educational Requirements & Work Experience:

• 1-3 years of experience in Regulatory Affairs
• Software medical device experience a plus

This position has an estimated base salary of $90,000 - $105,000, cash bonus, and stock options.

Heartflow is an Equal Opportunity Employer. We are committed to a work environment that supports, inspires, and respects all individuals and 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.

Positions posted for Heartflow are not intended for or open to third party recruiters / agencies. Submission of any unsolicited resumes for these positions will be considered to be free referrals.

Create a Job Alert

Interested in building your career at Heartflow? Get future opportunities sent straight to your email.

Apply for this job

indicates a required field

First Name *

Last Name *

Email *

Phone *

Resume/CV *

Enter manually

Accepted file types: pdf, doc, docx, txt, rtf

Enter manually

Accepted file types: pdf, doc, docx, txt, rtf

Education

School * Select...

Degree * Select...

Select...

Are you legally authorized to work in the US? * Select...

Will you now, or in the future, require sponsorship for employment visa status (eg. H1B, etc)? * Select...

How did you hear about this job? *

Job site

LinkedIn

Indeed

Employee

Handshake

Other

What are your base salary expectations for this role? *

How many years of Regulatory Affairs experience do you have? *

Less than 3

5 years

More than 5 years

Please expand. *

Do you have software medical device experience? * Select...

If yes, please expand *

Are any of your immediate family members practicing health care professionals that may use or purchase HeartFlow products? * Select...

If answered Yes, please provide the name of the relative and the name of the organization in which they are employed.

Do you have any immediate family that work at HeartFlow? * Select...

If answered Yes, please provide the name of the employee who works at HeartFlow.

Have you ever been or currently debarred by the U.S. FDA or excluded by the OIG? * Select...

Which state do you reside in? * Select...

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.

As set forth in Heartflow’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Select...

Voluntary Self-Identification of Disability

Form CC-305

Page 1 of 1

OMB Control Number 1250-0005

Expires 04/30/2026

Voluntary Self-Identification of Disability

Form CC-305 Page 1 of 1 OMB Control Number 1250-0005 Expires 04/30/2026
Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp .

How do you know if you have a disability?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

• Alcohol or other substance use disorder (not currently using drugs illegally)
• Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
• Blind or low vision
• Cancer (past or present)
• Cardiovascular or heart disease
• Celiac disease
• Cerebral palsy
• Deaf or serious difficulty hearing
• Diabetes
• Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
• Epilepsy or other seizure disorder
• Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
• Intellectual or developmental disability
• Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
• Missing limbs or partially missing limbs
• Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
• Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
• Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
• Partial or complete paralysis (any cause)
• Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
• Short stature (dwarfism)
• Traumatic brain injury

Disability Status Select...

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.