International Regulatory Affairs Lead (Medical Devices)

International Regulatory Affairs Lead (Medical Devices) Cupertino, California, United States Hardware The Health group is looking for an International Regulatory Affairs Lead to head a team responsible for international expansion of Apple Health’s regulated medical device features. If you are passionate about the health space and want to have an incredible impact here at Apple, this could be the role for you. We are an efficient organization who 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. Description 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. 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 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 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 $214,000 and $356,600, 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: Apple benefit, compensation and employee stock programs are subject to eligibility requirements and other terms of the applicable plan or program. Apple is an equal opportunity employer that is committed to inclusion and diversity. We seek to promote equal opportunity for all applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, Veteran status, or other legally protected characteristics. Learn more about your EEO rights as an applicant. At Apple, we believe accessibility is a fundamental human right. You’ll find that idea reflected in everything here — in our culture, our benefits and our digital tools. By welcoming as many perspectives as possible, we help you build a career where you feel like you belong. Learn about accessibility in Apple’s workplace. Learn about reasonable accommodations for job applicants. Apple accepts applications to this posting on an ongoing basis. #J-18808-Ljbffr