The Regulatory Specialist is comfortable with FDA regulation of software embedded in or as a medical device.
The right person for the job has 3 – 5 years’ experience in Regulatory with a full 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 bringing HeartFlow medical device product(s) to market.
- Participate in the risk assessment and evaluation process to ensure risks are identified and mitigated during development
- Ensure communication and awareness of product features from early development stage in order to make appropriate regulatory assessment
- Support completion of regulatory requirements for market entry. Work with international distributors and in-country caretakers to achieve and maintain regulatory approvals world wide
- Support quality system compliance related to commercialization
- Support new and maintenance development projects for HeartFlow product portfolio
- Support Quality System management, as needed
- Ability to work in a fast-paced adaptive environment, self-starter and strong team player required.
- In-depth knowledge of US, Canadian and/or EU regulatory requirements
- Strong team player who is able to ask the right questions for strategic product planning and development; in-depth knowledge of ISO 13485 design control requirements, and familiarity with EN 62304 preferred.
- Excellent communication, writing and editing skills
- Strong Word, Excel and PowerPoint skills
Educational Requirements & Work Experience:
- 3 – 5 years’ experience in Regulatory with a full understanding of regulatory requirements
- Prior exposure to regulatory submission generation for FDA, and one or more of the following: PMDA, EU, Health Canada, etc., [e.g., 510(k)s, Technical Files, PMAs], including authoring and review of content.
- Experience with software medical device product in an agile/scrum development environment strongly preferred
- Knowledge with software engineering/programming strongly preferred
About HeartFlow, Inc.
HeartFlow, Inc. is a medical technology company redefining the way heart disease is diagnosed and treated. Our non-invasive HeartFlow FFRct Analysis leverages deep learning to create a personalized 3D model of the heart. By using this model, clinicians can better evaluate the impact a blockage has on blood flow and determine the best treatment for patients. Our technology is reflective of our Silicon Valley roots and incorporates decades of scientific evidence with the latest advances in artificial intelligence. The HeartFlow FFRct Analysis is commercially available in the United States, Canada, Europe and Japan. For more information, visit www.heartflow.com.
HeartFlow, Inc. is an Equal Opportunity Employer. This company does not and will not discriminate in employment and personnel practices on the basis of race, sex, age, handicap, religion, national origin or any other basis prohibited by applicable law. Hiring, transferring and promotion practices are performed without regard to the above listed items.
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.