Regulatory Affairs Associate (Principal) - Medical Devices

Apple • Cupertino, CA

2d • Hybrid

About The Position

The  Health group is looking for a Principal Regulatory Affairs Associate to help drive strategy and submissions for health products. This role is for individuals passionate about the health space who want to have an incredible impact. The team is efficient, works closely together, and builds relationships across multiple functional teams. They care deeply about getting amazing new products into customers' hands and think creatively about launching products within a rigorous regulatory structure for medical devices.

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 onsite; this role is a hybrid, in-person position.

Nice To Haves

• Global regulatory strategy experience (e.g., EU MDR) is a strong plus.
• Demonstrable background in being autonomous and being able to clearly work towards established 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.

Responsibilities

• 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.
• 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, including identification of assumptions/risks/mitigations.
• Develop and execute clear regulatory plans in the US and globally.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal