Summary

Posted: Feb 22, 2021

Weekly Hours: 40

Role Number:200224175

The Health group is looking for a Principal Regulatory Affairs Associate to help drive strategy and submissions...Summary

Summary

Posted: Feb 22, 2021

Weekly Hours: 40

Role Number:200224175

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.

Key Qualifications

• 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 regulatory health authorities, both in the US and abroad
• Preparing global product submissions required including STED, CDST and other global templates.
• Strong working knowledge of US, EU, APAC, LATAM, ASEAN and other global regulations that affect Class I, II and III devices
• Strong knowledge of US and global regulations

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.

Education & Experience

B.S. ME/EE/BME/CS degree or equivalent in any engineering discipline

Additional Requirements

• 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