Principal International Regulatory Affairs Associate

Apple•Cupertino, CA

7d•Onsite

About The Position

Our ever-evolving suite of Health and Wellness products for iPhone and Watch is helping our users live more active, healthier lives. Be ready to make something great when you come here. Dynamic, inspiring people and innovative, industry-defining technologies are the norm at Apple. The people who work here have reinvented and defined entire industries with our products and services. That same spirit of innovation drives our Health projects, where cross-functional teams collaborate closely to explore ambitious ideas in their earliest stages. Our dedication to innovation also extends to our business practices, strengthening our commitment to leave the world better than we found it. The  Health group is looking for an experienced Regulatory Affairs professional with global expertise to lead a special project involving large-scale, multi-functional collaboration across Apple. If you are passionate about the health space and want to make a meaningful impact here at Apple, this could be the role for you. We are a lean, collaborative organization that works closely across multiple teams. We care deeply about getting amazing new products into our customers’ hands. You will represent the International Regulatory Affairs team on a high-impact, collaborative project. In partnership with regional RA experts, you will develop, articulate, and drive the global regulatory strategy for innovative pipeline features. You will proactively address regulatory challenges, make informed decisions, and communicate appropriate regulatory actions. Additionally, you will develop engagement strategies with global health authorities to facilitate the regulatory pathway and support launch plans as needed. This is site-based role.

Requirements

Bachelor’s degree or equivalent in science or engineering
10+ years of experience in regulatory affairs
Regulatory expertise in one or more key markets such as EU/UK, China, or Japan
Proven ability to work autonomously and drive established goals and initiatives with minimal supervision
Executive presence and poise, demonstrated through a strong track record of positively influencing decisions and cross-functional teams

Nice To Haves

Masters / PhD / post-secondary education preferred
Experience working with the SaMD product and wearable technology
Experience navigating regulatory environment in emerging markets
Excellent verbal and written communication skills

Responsibilities

Develop and implement comprehensive global regulatory strategies for Apple Health features
Collaborate closely with multi-functional teams across Apple to communicate regulatory plans clearly and maintain alignment throughout development
Lead and handle regulatory authority interactions and negotiations, advocating for Apple’s position while ensuring compliance and timely approvals
Identify potential regulatory risks and opportunities early by engaging with global regulatory landscapes, and advise internal teams to inform product development and strategy
Partner with internal partners and external bodies to influence and shape emerging regulations and guidances that impact Apple Health initiatives

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