Offer summary

Qualifications:

Bachelor’s degree in a relevant field., 1-3 years of experience in Regulatory Affairs., Base knowledge of global regulatory requirements., Strong communication, writing, and editing skills..

Key responsabilities:

Support minor software releases by performing change assessments.

Collaborate with cross-functional teams for regulatory project management activities.

Manage new product registrations and maintain global regulatory approvals.

Conduct regulatory surveillance and communicate changes in regulations and standards.

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_CTAnalysis—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 (RoadMap™Analysis), assess coronary blood flow (FFR_CTAnalysis), 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:

Bachelor’s degree
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.

Required profile