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Regulatory Affairs Manager

2 months ago

Mountain View, California, United States HeartFlow Full time
Job Title: Sr. Manager, Regulatory Affairs

At HeartFlow, Inc., we are revolutionizing precision heart care with our cutting-edge technology. We are seeking a highly skilled Sr. Manager, Regulatory Affairs to join our team and play a critical role in ensuring the successful development and market entry of our medical devices.

Job Summary:

The Sr. Manager, Regulatory Affairs will be responsible for overseeing all activities related to regulatory approval to market our devices. This includes pre-market development, new and continuing market entry, and post-market surveillance. The ideal candidate will have a deep understanding of worldwide product regulation/registration pathways, medical device regulations, and applicable standards.

Key Responsibilities:
  • Manage worldwide submissions for new products and product changes to ensure timely approval for clinical studies and market release.
  • Keep informed of new regulations and requirements and interpret for regulatory education and guidance within the organization.
  • Collaborate with key internal partners and other stakeholders to support a globally effective and compliant organization.
  • Prepare regulatory strategies/plans and worldwide requirements lists.
  • Provide on-going support to core and project teams for regulatory issues and questions.
  • Effectively monitor and ensure applicable regulatory requirements are considered and appropriately incorporated into all programs.
  • Ensure all reporting requirements to external regulatory authorities are completed accurately and on time.
Requirements:
  • Deep knowledge and understanding of worldwide product regulation/registration pathways, medical device regulations, and applicable standards.
  • Experience working with regulated software medical devices, including application of 62304 and an agile/scrum development environment.
  • Successful domestic and international regulatory submission track record.
  • Excellent verbal and written communications skills.
  • Direct experience with external audits/inspections.
  • Demonstrated ability to independently assess risk and develop imaginative, thorough, and practical solutions to critical and difficult problems.
Education and Experience:

Bachelor's Degree and 8+ years of regulatory medical device experience, including 5+ years of management experience.

We offer a competitive salary range of $170,000 to $220,000 per year, cash bonus, and stock options. HeartFlow, Inc. is an Equal Opportunity Employer and is committed to a work environment that supports, inspires, and respects all individuals.