International Regulatory Affairs Lead (Medical Devices)

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

Ability to be onsite; this role is a hybrid, in-person position

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