Principal International Regulatory Affairs Associate at Apple

Cupertino, California, United States -

Full Time

Start Date

Immediate

Expiry Date

23 Apr, 26

Salary

0.0

Posted On

23 Jan, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

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

Industry

Computers and Electronics Manufacturing

Description

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. 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

Responsibilities

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.