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 Preferred Qualifications 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 Minimum Qualifications 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 Ability to be onsite; this role is a hybrid, in-person position Pay & Benefits At Apple, base pay is one part of our total compensation package and is determined within a range. This provides the opportunity to progress as you grow and develop within a role. The base pay range for this role is between $218,300 and $363,700, and your base pay will depend on your skills, qualifications, experience, and location. Apple employees also have the opportunity to become an Apple shareholder through participation in Apple's discretionary employee stock programs. Apple employees are eligible for discretionary restricted stock unit awards, and can purchase Apple stock at a discount if voluntarily participating in Apple's Employee Stock Purchase Plan. You'll also receive benefits including: Comprehensive medical and dental coverage, retirement benefits, a range of discounted products and free services, and for formal education related to advancing your career at Apple, reimbursement for certain educational expenses - including tuition. Additionally, this role might be eligible for discretionary bonuses or commission payments as well as relocation. Learn more about

Apple Benefits Note:

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