Job Responsibilities
- Support frequent mior 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, a cash bonus and stock options. HeartFlow is a mature start-up, pre-ipo market place leader, changing the paradigm in Coronary Artery Disease Diagnostics.
HeartFlow, Inc. 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.
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