Digital Health Regulatory Affairs Manager

About the role

For our client, we are seeking a Digital Health Regulatory Affairs Manager to join the team of a leader in the Healthcare space. This role will guide regulatory strategy for digital health and connected medical device programs, with a strong emphasis on FDA submissions and cybersecurity considerations. You will partner closely with global regulatory stakeholders, product development teams, and internal reviewers to support approvals across key markets. The position is highly focused on Class II and III cardiovascular devices, helping shape compliant pathways from development through submission and product lifecycle changes. Location: Remote - US based candidates only, no visa sponsorship available.

Responsibilities

• Lead regulatory strategies for obtaining FDA clearance or approval for Class II and III cardiovascular medical devices.
• Act as a liaison for global regulatory teams, ensuring alignment on product approvals across geographies.
• Prepare and review FDA submissions and respond to pre-submission inquiries during review periods.
• Provide regulatory support for new product development with a focus on cybersecurity and software components.
• Evaluate regulatory implications for changes to existing products and facilitate necessary filings.
• Stay updated on global digital health regulations and their impact on submission strategies.
• Assist in maintaining and improving regulatory SOPs related to digital health.

Qualifications

• Regulatory Affairs experience in medical devices with a successful FDA submission track record, particularly in cybersecurity (524B compliance).
• Minimum of 6 years of experience with a Bachelor's degree, or at least 5 years with an advanced degree in regulatory affairs.
• Successful history of IDE/PMA/510(k) device submissions, especially Class III involving software and hardware components.
• Experience communicating with FDA reviewers and leading Q-sub meetings effectively.
• Familiarity with global digital health regulations and guidance, including ISO standards and cybersecurity compliance.

Benefits

• Remote work flexibility available for all U.S. states.
• Opportunities for annual performance bonuses based on individual and company performance.
• Access to comprehensive medical, dental, and vision insurance plans.
• Retirement savings options through a consolidated retirement plan and 401(k).
• Generous vacation and sick leave policies, with additional holidays and floating days.

Pay

Compensation: $117,000 – $201,250 annually