Manager of Regulatory Affairs (International)
Santa Clara Valley (Cupertino), California, United States
Operations and Supply Chain
The Health group is looking for a Manager of Regulatory Affairs (International) to help lead and execute on strategy and submissions for health products globally. If you are passionate about the health space and want to have an impact here at Apple, this could be the role for you. We are an efficient organization who works closely together to form relationships across multiple functional teams. We care deeply about getting amazing new products into our customers hands.
- 10+ years of medical device experience in a regulatory role, with at least 5+ years as a senior manager, director or equivalent in a medical device company
- Significant experience in leading interactions with regulatory health authorities in the US and abroad
- Preparing global product submissions required including STED, CDST and other global templates
- Solid understanding 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
- Previous experience leading and supporting regulatory policy efforts internationally
- Expertise in building, scaling and developing international expansion programs, including processes, resources and tools
You will lead a team of International Regulatory Affairs associates and represent the Regulatory team on a diverse array of initiatives and new product development programs, with the goal of marketing new technologies. You will demonstrate the ability to develop a variety of solutions to regulatory challenges and will exercise independent judgment in settling and communicating appropriate regulatory action and requirements. This role will involve assessment of regulatory impact for new and modified Class I, II and III products, including identification of assumptions/risks/mitigations to develop and execute clear regulatory plans in the US and globally. You’ll also be responsible for establishing a team culture and process for executing the above tasks in creative ways that still meets regulatory and legal frameworks.
Education & Experience
- B.S. degree or equivalent in a life science, legal or business field. - M.S/ PhD/ post-secondary education preferred
- - Advanced knowledge of management techniques and practices including day-to-day management and building a team culture
- - Proven background in being autonomous and being able to clearly work towards establish goals and initiatives with minimal oversight.
- - Consistent track record in leading and scaling a Regulatory team while delivering on individual goals
- - Shown 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 strategy and “look around corners” to anticipate business impact
- - Good organizational and management skills.
- - Excellent communication skills, both verbal and written
- Apple is an Equal Opportunity Employer that is committed to inclusion and diversity. We also take affirmative action to offer employment and advancement opportunities to all applicants, including minorities, women, protected veterans, and individuals with disabilities. Apple will not discriminate or retaliate against applicants who inquire about, disclose, or discuss their compensation or that of other applicants.