Apple · 20 hours ago
International Regulatory Affairs Lead (Medical Devices)
Cupertino, California, United States
Full-time
Onsite
Lead/Staff
$214K/yr - $357K/yr
10+ years expApple is looking for an International Regulatory Affairs Lead to head a team responsible for international expansion of Apple Health’s regulated medical device features. The role involves leading assessments of regulatory impact for new and modified wellness products and developing solutions to regulatory challenges while overseeing a team of global regulatory experts.
AppsArtificial Intelligence (AI)BroadcastingDigital EntertainmentFoundational AIMedia and EntertainmentMobile DevicesOperating SystemsTVWearables
Responsibilities
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 will 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/mitigations to develop and execute clear regulatory plans across the globe
In this leadership role, you will also:
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 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 in order to drive RA/QA strategy for international expansion programs
Qualification
Required
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 in leading and overseeing international programs
Proven track record in overseeing a large scope of international regulatory affairs matters including regulatory approvals, submissions, launch strategy
Experience leading global team of regulatory professionals, including establishing organizational objectives and proven success delivering as a team
Significant experience in crafting strategy interactions with regulatory health authorities in the US and abroad
Demonstrable track record of receiving regulatory approvals for complex products - including software medical devices - globally, across US, 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 US, 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 US and abroad
Significant expertise in global quality standards, including ISO 13485, ISO 14155, and related technical product-specific standards
Preferred
M.S./ PhD / post-secondary education preferred
Demonstrable background in being autonomous and being able to clearly work towards establish goals and initiatives with minimal oversight
Proven competence in determination of 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 “look around corners” to anticipate business impact
Strong organizational and management skills
Excellent communication skills, both verbal and written
Comfortable with presenting assessments and information to broad, multi-disciplinary teams
Benefits
Comprehensive medical and dental coverage
Retirement benefits
A range of discounted products and free services
Reimbursement for certain educational expenses — including tuition
Discretionary bonuses or commission payments
Relocation
Company
Apple
Apple is a technology company that designs, manufactures, and markets consumer electronics, personal computers, and software.
10001+ employees
H1B Sponsorship
Apple has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
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2023 (3939)
2022 (4822)
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2020 (3656)
Funding
Current Stage
Public CompanyTotal Funding
$5.67BKey Investors
Berkshire HathawayMicrosoftSequoia Capital
2025-05-05Post Ipo Debt· $4.5B
2025-01-16Post Ipo Debt· $0.31M
2021-04-30Post Ipo Equity
Leadership Team
Tim Cook
CEO
Craig Federighi
SVP, Software Engineering
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