Regulatory Affairs Associate (Principal) - Medical Devices

Job description

Imagine what you could do here. At Apple, excellent ideas have a way of becoming great products, services, and customer experiences. Bring passion and dedication to your job, and there’s no telling what you could accomplish. The people at Apple don’t just build products — we craft the kind of wonder that’s revolutionized entire industries.

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.
<h3>Minimum Qualifications</h3>B.S. ME/EE/BME/CS degree or equivalent in any engineering discipline
10+ years of medical device experience in a regulatory role, with 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 onsite; this role is a hybrid, in-person position.
<h3>Preferred Qualifications</h3>Global regulatory strategy experience (e.g., EU MDR) is a strong plus.
Demonstrable 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.
Proven competence in determination of appropriate global regulatory requirements for new products or product changes.
Partnering with and across engineering teams to set regulatory strategy.
Strong organizational and management skills.
Excellent communication skills, both verbal and written.