Senior Regulatory Affairs Specialist

The Senior Regulatory Affairs Specialist is responsible for coordinating and supporting regulatory activities pertaining to successful pre-market development, continued new market entry, and post-market activities for Heartflow products.

This individual contributor role provides world-class regulatory support for Heartflow products, ensuring compliance with applicable global requirements while proactively navigating evolving regulatory landscapes.

This position is responsible for activities related to regulatory approval to market Heartflow products from development to post-market surveillance.  He/she will be responsible for the assessment of device changes for regulatory impact and develop strategies for submissions and maintenance of documentation within the shifting framework of regulatory requirements worldwide in an efficient manner.  

Job Responsibilities:

Regulatory Project Management

• Represent Regulatory Affairs on cross-functional teams (as necessary) to ensure regulatory alignment with business objectives and timely submissions.
• Facilitate development of global regulatory strategies for Heartflow products through interfacing with internal (product teams) and external partners (distributors, authorized representatives, international regulatory team).
• Review regulatory strategies with the RA management team to gain alignment on priorities and understanding of risks.
• Establish and maintain collaborative relationships and open communication channels with regulatory authorities and ensure all reporting requirements to external regulatory authorities are completed accurately and on time.

Regulatory Operations and Compliance

• Maintain regulatory pre-market and post-market commitments and compliance (establishment registrations, certifications, reporting, special controls, etc) and related activities.
• Support development of SOPs and internal guidance.
• Ensure applicable regulatory requirements are considered and appropriately incorporated into projects to ensure compliance.
• Manage worldwide submissions for new products and product changes as required to ensure timely approval for clinical studies and/or market release. 
• Provide on-going support to core and project teams for regulatory issues and questions. Find, interpret, and apply regulations and guidance appropriately for situations. 
• Support Quality organization as necessary in audits and initiatives.

Skills Needed:

• Familiarity with current regulatory thinking around software and AI medical device software development.
• Direct experience with previously demonstrated examples for generating modular submission documentation and working with various regulatory agencies (e.g. FDA, Notified Bodies).
• Strong problem-solving skills and the ability to work independently as well as collaboratively in a team environment.
• Leadership and interpersonal skills to develop and manage good working relationships within Regulatory Affairs and with other internal departments (R&D, Product, Quality etc).
• Excellent communication (written and verbal) and stakeholder management skills to facilitate collaboration across teams and external partners.
• Strong project management skills with the ability to coordinate cross-functional teams and manage multiple regulatory projects/initiatives.

Educational Requirements & Work Experience:  

• Bachelor's degree in Science, Engineering, or a related field
• Minimum of 3 years of Regulatory Affairs medical device experience
• 1 year working with software as a medical device (SaMD) preferred

This position has an estimated base salary of $110,000 - $150,000 and bonus. #LI-IB1