Sr. Director of Regulatory Affairs

Company: Prodigy Search Group

Position: Sr. Director of Regulatory Affairs

Location: San Francisco, CA - primarily remote

Posted: January 3, 2022

 

 THE COMPANY

Our client is a leading digital healthcare company focused on the way cardiac arrhythmias are clinically diagnosed by combining wearable bio-sensing technology with powerful cloud-based data analytics and Artificial Intelligence capabilities. Their goal is to be the leading provider of ambulatory ECG monitoring for patients at risk for arrhythmias. Their continuous ambulatory monitoring has already put over 2 million patients and their doctors on a shorter path to what they both need – answers.

 

THE POSITION

We are currently seeking an experienced Senior Director of Regulatory Affairs who will own global regulatory strategies as well as manage and develop a growing team of talented Regulatory Affairs professionals. Reporting to the VP of Quality and Regulatory, this leader will have a significant role in shaping the regulatory strategy and market expansion strategies while providing strategic decision making and team coaching and development. The Regulatory Affairs team is directly involved in innovation R&D projects, including AI based Software as a Medical Device (SaMD), as well as strategic projects such as the EU MDR transition. The company work environment is fast-paced, with a collaborative atmosphere. Most of all, our client is passionate about delivering innovations that improve the quality of health care and the patient experience. They are looking for like-minded individuals to join their team today!

Specific job responsibilities include:

  • Develop U.S. and international regulatory strategies, including for AI based SaMD, with a team of talented Regulatory professionals.
  • Build, develop, and coach regulatory talent and capabilities.
  • Inspire, motivate and communicate Regulatory vision to associates and peers throughout the organization.
  • Assure timely regulatory clearances and registrations in support of key product launches through continuous improvement of processes, submissions, and regulatory strategies.
  • Lead EU MDR and UKCA transitions for existing and future portfolio of products.
  • Collaborate with Quality and R&D team leadership to continuously improve and develop processes to enhance conformity and compliance while accelerating market access.
  • Act as the key contact with regulatory agencies such as FDA and EU/UK Notified Bodies.
  • Partner with R&D and Product Management leaders to develop and implement strategies for pipeline development.
  • Lead Regulatory Affairs Policy Intelligence to monitor and influence the regulatory environment globally and provide assessments to the company’s cross-functional teams.

 

QUALIFICATIONS

  • Bachelor's degree required ideally in Engineering, Computer Science, or related medical/science/healthcare field, or equivalent experience.
  • Minimum of 15 years of professional experience in quality and regulatory roles in the medical device field, with a requirement of at least 10 years of experience in a management position.
  • Direct experience with FDA submissions required.  Experience with EU MDR transition preferred.
  • Thorough knowledge of medical device design control and risk management processes and regulations, including software as a medical device.
  • Experience working directly with regulatory agencies such as FDA and EU Notified Bodies.
  • High-level analytical skills and ability to focus on detail.
  • Demonstrated comfort working in a dynamic, entrepreneurial environment where strong organizational, leadership, collaboration, and communication skills were required to be successful.
  • Proven capacity to collaborate and build positive relationships and trust over time with cross-disciplinary audiences.

If interested, please contact: tmccarthy@prodigysearchgroup.com