Regulatory Program Manager, Health

What you'll do

• Oversee regulatory submissions, launch readiness, design changes, and medical device policy activities for product portfolios.
• Coordinate activities and resolve problems by establishing a robust understanding of the overall critical path.
• Communicate program status and escalate risks to a variety of internal and external stakeholders.
• Manage Quality Design History File (DHF) documentation timelines and execution across multiple cross-functional teams.
• Drive day-to-day program activities and timelines to meet overall program objectives.
• Generate and own reporting for regulatory and quality support initiatives.
• Conduct risk assessments to detect and mitigate potential issues during product launches.

What we're looking for

• Bachelor's degree in Engineering, Biomedical Science, or an equivalent science degree.
• 8+ years of program or project management experience in a regulated industry, preferably in medical products or digital health.
• Proven track record of driving regulatory submissions, quality system updates, regulator engagements, and launches with multi-disciplinary teams.
• Outstanding communication and organizational skills to manage multiple projects simultaneously.
• Excellent analytical and problem-solving capabilities to detect and mitigate risks.
• Hands-on experience using project management and reporting software.
• Ability to be onsite weekly for a hybrid, in-person position.
• Master's degree in Engineering, Biomedical Science, or an equivalent science degree (preferred).
• Direct hands-on experience with Design Controls and Quality Systems (preferred).
• Solid understanding of the regulatory process for different classes of medical devices in the US and international jurisdictions (preferred).