Principal International Regulatory Affairs Associate
full-time•Cupertino
About this role
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. Key responsibilities include: • 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. This is site-based role.
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
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
Description
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. Key responsibilities include: • 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. This is site-based role.
Minimum Qualifications
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
Preferred Qualifications
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
Other facts
Tech stack
Regulatory Affairs,Global Regulatory Strategy,Collaboration,Regulatory Challenges,Health Authorities Engagement,Product Development,Regulatory Risks,Wearable Technology,SaMD Product,Communication Skills,Negotiation,Compliance,Influencing Decisions,Cross-Functional Teams,Emerging Regulations,Health Initiatives
About Apple
We’re a diverse collective of thinkers and doers, continually reimagining what’s possible to help us all do what we love in new ways. And the same innovation that goes into our products also applies to our practices — strengthening our commitment to leave the world better than we found it. This is where your work can make a difference in people’s lives. Including your own.
Apple is an equal opportunity employer that is committed to inclusion and diversity. Visit apple.com/careers to learn more.
Team size: 10,001+ employees
Website: http://www.apple.com/careers
LinkedIn: Visit
Industry: Computers and Electronics Manufacturing
Founding Year: 1976
What you'll do
- You will represent the International Regulatory Affairs team on a high-impact, collaborative project and develop the global regulatory strategy for innovative pipeline features. Additionally, you will lead regulatory authority interactions and identify potential regulatory risks and opportunities.
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Frequently Asked Questions
What does a Principal International Regulatory Affairs Associate do at Apple?
As a Principal International Regulatory Affairs Associate at Apple, you will: you will represent the International Regulatory Affairs team on a high-impact, collaborative project and develop the global regulatory strategy for innovative pipeline features. Additionally, you will lead regulatory authority interactions and identify potential regulatory risks and opportunities..
Why join Apple as a Principal International Regulatory Affairs Associate?
Apple is a leading Computers and Electronics Manufacturing company.
Is the Principal International Regulatory Affairs Associate position at Apple remote?
The Principal International Regulatory Affairs Associate position at Apple is based in Cupertino, California, United States. Contact the company through Clera for specific work arrangement details.
How do I apply for the Principal International Regulatory Affairs Associate position at Apple?
You can apply for the Principal International Regulatory Affairs Associate position at Apple directly through Clera. Click the "Apply Now" button above to start your application. Clera's AI-powered platform will help match your profile with this opportunity and guide you through the application process. You can also learn more about Apple on their website.