Principal Consultant-Digital Health

Position Summary:

Freyr is seeking an experienced individual to join their Medical Device Team. This position involves working directly with clients with software enabled medical devices or software as a medical device to serve as an advisor on regulatory strategy including the development of regulatory strategy documents, documentation to support premarket submissions, and preparation and submission of premarket applications as well as participation in FDA meetings and other regulatory interactions. The role is 50% billable with the remaining time being devoted to business development/marketing as well as mentorship and training of the more junior staff.

The ideal candidate will possess in-depth knowledge of software enabled medical devices and Software as a Medical Device, including understanding relevant regulatory frameworks and software engineering principles. The candidate should have a terminal or advanced degree with at least 10 -15 years of experience with preparation of premarket submissions (or review of premarket submissions for FDA candidates). This experience should include an understanding of a broad range of software medical devices including digital health, medical imaging, clinical decision support, mobile medical apps, and AI/Machine Learning. The candidate should be able to advise clients on developing regulatory strategies for device development, including providing guidance on testing and documentation, labeling, and preparation of premarket submissions to FDA. This position requires strong written and oral communication skills, good people skills, and the ability to manage multiple competing priorities. Regulatory Affairs Certification (RAC) preferred but not required

Duties and Responsibilities:

To include the following and other duties as identified and assigned.

• Overarching responsibility for development and execution of innovative and robust regulatory strategies for medical device and digital health products, from early-stage development through to life-cycle management
• Writing and reviewing of regulatory documentation for the product development effort to include reviewing, editing, and coordination of document submissions to the FDA
• Responsible for ensuring regulatory goals, timelines and milestones are developed and adhered to, in alignment with strategic priorities of clients
• Preparing for and leading FDA meetings to include overall strategy development and FDA inquiry preparation for new device application meetings
• Act as senior advisor to more junior project leads
• Mentorship of junior team members and coordination of medical device project execution
• Stay abreast of changing trends and current events within the industry
• Provide scientific insight for new business development opportunities

Qualifications

• Demonstrated experience with premarket submissions for software enabled medical devices and Software as a Medical Device
• Working knowledge of and experience developing regulatory strategies and submissions for AI / ML devices, clinical decision support, and mobile medical apps. An understanding of FDAs regulatory framework for general wellness products is a plus.
• At least Bachelor of Science in life sciences or engineering and 10+ experience in an industry, consulting or regulatory environment with hands on experience with software enabled or SaMD medical device submissions to the Food and Drug Administration.
• In-depth knowledge of FDA regulations and guidance for the premarket submission process as well as hands-on experience drafting all types of medical device FDA submissions (e.g. Q-Submissions, 510(k), PMA, IDE, De Novo, etc.)
• Understanding and application of FDAs new Quality Management Systems Regulation (QMSR) devices is a plus.
• Experience with medical device regulatory requirements outside the US is a plus.
• Experience developing communications to regulatory bodies, providing written responses and updates, leading agency meetings
• Must exercise attention to detail, excellent computer skills, excellent oral and written communication skills, team player, organized analytical thinker with a high level of energy and self-motivation
• Having an intuition for the needs of the client and the ability to adjust to those
• Understanding and Handson experience using IEC 62304
• Understanding Cybersecurity requirements and Human Factors engineering requirements is a Plus