Principal Regulatory Affairs Associate

24 May, 2023


Principal Regulatory Affairs Associate

Apple Health Group
Santa Clara Valley (Cupertino), CA


Weekly Hours: 40
Role Number:200478600
The  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.
Key Qualifications
  • 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.
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 assessment of regulatory impact for new and modified Class I, II and III products, including identification of assumptions/risks/mitigations to develop and implement clear regulatory plans in the US.
Education & Experience
B.S. ME/EE/BME/CS degree or equivalent in any engineering field
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
Pay & Benefits

Job posted: 2023-05-24