Regulatory Affairs Associate (Principal) - Medical Devices

Apple•Cupertino, CA

1d•Hybrid

About The Position

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 incredible 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 rigorous 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 obtaining 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 execute clear regulatory plans in the US and globally.

Requirements

B.S. ME/EE/BME/CS degree or equivalent in any engineering discipline
10+ years of medical device experience in a regulatory role
At least 5+ 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
Experience with Software as a Medical Device (SaMD) and algorithm- or sensor-based products, including how regulatory strategy interacts with clinical study design and algorithm performance
Ability to be autonomous and work towards established goals and initiatives with minimal oversight
Strong organizational and management skills
Excellent communication skills, both verbal and written

Nice To Haves

Global regulatory strategy experience (e.g., EU MDR) is a strong plus.

Responsibilities

Represent the RA/QA team on regulatory initiative teams and new product development.
Develop a variety of solutions to regulatory challenges.
Exercise independent judgment in settling and communicating appropriate regulatory action and requirements.
Assess regulatory impact for new and modified Class I, II and III products.
Identify assumptions/risks/mitigations to develop and execute clear regulatory plans in the US and globally.
Lead interactions with the US Food & Drug Administration.
Prepare regulatory filings, including pre-submissions, 510(k)s, De Novos, and IDEs.
Determine appropriate global regulatory requirements for new products or product changes.
Partner with and across engineering teams to set regulatory strategy.
Work as part of a focused project team.