International Regulatory Affairs Lead; Medical Devices

International Regulatory Affairs Lead (Medical Devices)

Cupertino, California, United States – Hardware

We are looking for an International Regulatory Affairs Lead to head a team responsible for the international expansion of Apple Health’s regulated medical device features. If you are passionate about the health space and want to make an incredible impact, this could be the role for you. We are an efficient organization that works closely together to build relationships across multiple functional teams.

We care deeply about getting amazing new products into our customers’ hands across the globe.

You will be the primary leadership team member on the Health Regulatory Affairs team, representing the team on a diverse array of initiatives and new product development programs, with the goal of marketing new technologies in all of Apple’s international geographies. You will develop a variety of solutions to regulatory challenges and exercise independent judgment in settling and communicating appropriate regulatory/quality strategy, actions, and requirements while overseeing a team of global regulatory experts across all geographies.

This role will involve leading assessments of regulatory impact for new and modified wellness, Class I, II, and III products, including identification of assumptions, risks, and mitigations to develop and execute clear regulatory plans across the globe.

• Represent the Health Regulatory Affairs team in executive meetings and reviews for topics representing our international expansion work.
• Identify regulatory trends and opportunities that impact the strategic direction of Apple Health, and establish/implement plans that ensure sustained growth of business in each region.
• Build strong relationships with external stakeholders, including regulators and trade groups, across key global markets.
• Partner with cross‑functional partners including Legal, Government Affairs, Policy, Quality, and other external stakeholders.
• Set frameworks for technical writing, including distilling complex information into geo‑specific filings, submissions, slides, and other communication formats.
• Execute complex gap analyses for products/programs against global regulations, standards and guidance to drive RA/QA strategy for international expansion programs.

• B.S. degree or equivalent in a life science, legal, or business discipline.
• 10+ years of medical device experience in a regulatory and/or quality executive role, with at least 5+ years focused on leading and overseeing international programs.
• Proven track record in overseeing a large scope of international regulatory affairs matters including regulatory approvals, submissions, and launch strategy.
• Experience leading a global team of regulatory professionals, including establishing organizational objectives and proven success delivering as a team.
• Significant experience crafting strategy interactions with regulatory health authorities in the U.S. and abroad.
• Demonstrable track record of receiving regulatory approvals for complex products—including software medical devices—globally, across U.S., EU, APAC, LATAM, ASEAN, and other regions.
• Deep expertise in developing global product submissions, including STED, CDST, and other global templates.
• Strong working knowledge of U.S., EU, APAC, LATAM, ASEAN, and other global regulations that affect Class I, II, and III devices.
• Strong knowledge of clinical investigations, validations, and GCP requirements in the U.S. and abroad.
• Significant expertise in global quality standards, including ISO 13485, ISO 14155, and related technical product‑specific standards.
• Ability to be onsite; this role is a hybrid, in‑person position.

• M.S., Ph.D., or post‑secondary education preferred.
• Demonstrable background in being autonomous and working towards establishing goals and initiatives with minimal oversight.
• Proven competence in determining appropriate global regulatory requirements for new products or product changes.
• Partnering with and across a broad swath of other Apple teams to set regulatory/quality strategy and anticipate business impact.
• Strong organizational and management…