Regulatory Program Manager, Health

Apple • Cupertino, CA

6d • Hybrid

About The Position

The Regulatory Program Manager provides regulatory and quality support for regulatory submissions, product launches, design changes, and policy engagements. The role collaborates with regulatory, quality, clinical, marketing, and engineering teams to drive global launches of regulated health features. The manager drives day-to-day program activities and timelines, owns reporting, and conducts risk assessments to meet program objectives. This hybrid, in-person position requires weekly onsite work and may involve occasional travel.

Requirements

• Bachelor's degree in Engineering, Biomedical Science, or an equivalent science degree.
• At least 8 years of program or project management experience in a regulated industry, preferably medical products and/or digital health.
• Proven track record of driving regulatory submissions, quality system updates, regulator engagements, and launches with multidisciplinary teams.
• Outstanding communication and organizational skills, with the ability to manage multiple projects simultaneously.
• Excellent analytical and problem-solving capabilities, with a keen eye for detecting and mitigating risks.
• Independent self-starter who thrives in ambiguous environments.
• Hands-on experience using project management and reporting software.
• Ability to work onsite weekly.

Nice To Haves

• Master's degree in Engineering, Biomedical Science, or an equivalent science degree.
• Direct hands-on experience with Design Controls and Quality Systems.
• Solid understanding of regulatory processes for different classes of medical devices in the United States and international jurisdictions.

Responsibilities

• Provide regulatory and quality support for regulatory submissions, product launches, design changes, and policy engagements.
• Collaborate with cross-functional teams to drive global product launches.
• Support regulatory submissions, design changes, and external engagements.
• Drive day-to-day program activities and timelines.
• Generate and own program reporting.
• Conduct risk assessments to meet overall program objectives.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior