Apple is inviting applications from eligible candidates for the role of Principal Regulatory Affairs Associate for its office in Santa Clara Valley (Cupertino), California.
About Apple
Apple Inc. is an American multinational technology company headquartered in Cupertino, California. Apple is the world’s largest technology company by revenue, with US$394.3 billion in 2022 revenue. As of March 2023, Apple is the world’s biggest company by market capitalization.
About the Role
The Apple Health group is looking for a Principal Regulatory Affairs Associate to help drive strategy and submissions for health products. 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 team who works closely together to build relationships across multiple functional teams. We care deeply about getting amazing new products into our customers’ hands. We come to Apple to think creatively about how to launch products within a detailed regulatory structure for medical devices.
You will represent the RA/QA team on a diverse array of regulatory initiative teams and new product development, with the goal of acquiring approvals for 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 the assessment of regulatory impact for new and modified Class I, II and III products, including the identification of assumptions/risks/mitigations to develop and implement clear regulatory plans in the US.
Educational Qualifications
B.S. ME/EE/BME/CS degree or equivalent in any engineering field
Experience
- 7+ years of medical device experience in a regulatory role, with at least 2 years as a principal, manager or lead.
- Significant experience in leading interactions with the US Food & Drug Administration
- Significant experience preparing regulatory filings, including pre-submissions, 510(k)s, De Novos, and IDEs.
- Strong working knowledge of US regulations that affect Class I, II and III devices.
Additional Requirements
- Proven background in being autonomous and being able to clearly work towards establish goals and initiatives with minimal oversight.
- – Working as part of a focused project team.
- – Shown competence in determination of appropriate regulatory requirements for new products or product changes.
- – Partnering with and across engineering teams to set regulatory strategy
- – Strong organizational and leadership skills.
- – Excellent communication skills, both verbal and written.
Salary
The base pay range for this role is between $124,100 and $206,900, and your base pay will depend on your skills, qualifications, experience, and location.
