Regulatory Program Manager, Health

Apple • Cupertino, CA

5d • Hybrid

About The Position

The Regulatory Program Manager provides regulatory and quality support for submissions, product launches, design changes, and policy engagements for health and wellness products. The role collaborates with regulatory, quality, clinical, marketing, and engineering teams to advance regulated health features through global launch and support products with the potential to improve health outcomes worldwide.

The position drives day-to-day program activities and timelines, owns reporting, and conducts risk assessments to meet program objectives. It oversees regulatory submissions, launch readiness, design changes, and medical device policy activities across portfolios of work; coordinates critical-path activities and resolves issues with cross-functional partners; communicates status and escalates risks to stakeholders; and manages Quality Design History File (DHF) documentation timelines and execution. This is a hybrid, in-person role requiring weekly onsite work and may involve occasional travel.

Requirements

• Bachelor's degree in Engineering, Biomedical Science, or an equivalent science discipline.
• At least 8 years of program or project management experience in a regulated industry, preferably in medical products and/or digital health.
• Proven experience driving regulatory submissions, quality system updates, regulator engagements, and launches with multidisciplinary teams.
• Strong communication and organizational skills, with the ability to manage multiple projects simultaneously.
• Analytical and problem-solving capabilities, including the ability to identify and mitigate risks.
• Ability to work independently and thrive in ambiguous environments.
• Hands-on experience using project management and reporting software.
• Ability to work onsite weekly; the role is hybrid and in person.
• May require occasional travel.

Nice To Haves

• Master's degree in Engineering, Biomedical Science, or an equivalent science discipline.
• 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.
• Drive global product launches in collaboration with cross-functional teams, including regulatory submissions, design changes, and external engagement support.
• Drive day-to-day program activities and timelines, own reporting, and conduct risk assessments to meet program objectives.
• Oversee regulatory submissions, launch readiness, design changes, and medical device policy activities across portfolios of work.
• Maintain an understanding of the overall critical path, coordinate activities, and resolve problems with cross-functional partners.
• Communicate program status and escalate risks to stakeholders.
• Establish and manage Quality Design History File (DHF) documentation timelines and execution across cross-functional stakeholders.

What This Job Offers

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