Director - Quality Systems & Regulatory Affairs
The Director of Quality Systems & Regulatory Affairs will oversee activities pertaining to successful quality systems management, and regulatory involvement and actions supporting pre-market development and submissions, and post-market surveillance and compliance.
The right candidate will possess outstanding operational experience and skills including the demonstrated ability to design and improve quality and regulatory processes. This person will be responsible for working cross-functionally at all levels of the organization to ensure our systems are compliant and still effective to support an agile development environment.
This position is responsible for activities that lead to and maintain regulatory approval to market devices. This person will be responsible for the assessment of device changes for regulatory implications, and develop strategies for submissions and maintenance of documentation within the framework of regulatory requirements worldwide in an efficient manner. They will establish strategic plans and procedures at all levels to ensure that the company fulfills its obligations under FDA and international regulations for medical device manufacturers.
A minimum of 10 years of demonstrable, successful and relevant experience in quality and regulatory in the medical device industry is required, along with extensive knowledge of both regulatory and quality systems requirements for medical devices.
- Manage new product registrations / clearances / approvals, worldwide
- Interpreting new regulations and requirements as they relate to all operations of the company to provide quality/regulatory education and guidance within the organization
- Acting as primary liaison to Notified Body for planning and execution of required audits to maintain necessary certifications
- Collaborate cross-functionally to identify and drive process improvements
- Integrate into product development process, to support frequent cadence of product releases
- Supporting Quality and Regulatory teams in their day-to-day activities as necessary, providing guidance and decision authority
- Deep knowledge and understanding of the following regulations / standards / processes:
- Worldwide product regulation/registration pathways in particular US, EU, CAN, AUS, and JPN
- Medical device regulations
- Applicable standards including ISO 13485, ISO 14971, IEC 62304
- MDSAP auditing
- Successful domestic and international regulatory submission track record
- Experience working with regulated software medical device, including application of 62304 and an agile/scrum development environment
- Skilled at preparing, reviewing, editing, filing, and supporting various types of submissions including original and supplemental Investigational Device Exemptions (IDEs), Premarket Notifications w/ clinical data, and CE Design and Technical Dossiers.
- Utilizes knowledge of the regulatory requirements to support regulatory resources in determining the best risk management position to take on various issues.
- Common sense approach to creating value through compliance
- Ability to navigate the “greys” that exist between standards and business practice
- Approachable and able to interact and influence effectively at technical and management levels
- Excellent verbal and written communications skills evidenced by short approval times for product submissions and successful interactions with colleagues, consultants, and various regulatory agencies worldwide.
- Direct experience with external audits/inspections both general audits for compliance and pre-approval inspections for product registrations/submissions
Educational Requirements & Work Experience:
- Bachelor’s Degree
- Experience with multiple software programs and online tools
- 10+ years working in regulated industry, including 5+ years management experience, and 2+ years experience with regulated software product/practices
- ISO 13485:2016 and MDSAP training evidence and experience
- Prior experience as designated Management Representative preferred
- Excellent team player with ability to find and create consensus, and adept at working in the fast pace of a startup environment
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.