International Regulatory Affairs Lead (Medical Devices)

Apple • Cupertino, CA

8h

About The Position

The Apple Health group is looking for an International Regulatory Affairs Lead to head a team responsible for the international expansion of Apple Health’s regulated medical device features. This role is for individuals passionate about the health space who want to have an incredible impact. The team is an efficient organization that works closely together to build relationships across multiple functional teams and cares deeply about getting amazing new products into customers' hands across the globe.

Requirements

• 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.

Nice To Haves

• M.S./ PhD / post-secondary education preferred.
• Demonstrable background in being autonomous and being able to clearly work towards established 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.

Responsibilities

• Serve as 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.
• 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.
• Lead 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.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior