What are the responsibilities and job description for the Principal International Regulatory Affairs Associate position at Apple?
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
Preferred Qualifications
Pay & Benefits
At Apple, base pay is one part of our total compensation package and is determined within a range. This provides the opportunity to progress as you grow and develop within a role. The base pay range for this role is between $174,900 and $291,400, and your base pay will depend on your skills, qualifications, experience, and location.
Apple employees also have the opportunity to become an Apple shareholder through participation in Apple’s discretionary employee stock programs. Apple employees are eligible for discretionary restricted stock unit awards, and can purchase Apple stock at a discount if voluntarily participating in Apple’s Employee Stock Purchase Plan. You’ll also receive benefits including: Comprehensive medical and dental coverage, retirement benefits, a range of discounted products and free services, and for formal education related to advancing your career at Apple, reimbursement for certain educational expenses - including tuition. Additionally, this role might be eligible for discretionary bonuses or commission payments as well as relocation. Learn more about Apple Benefits.
Note: Apple benefit, compensation and employee stock programs are subject to eligibility requirements and other terms of the applicable plan or program.
Apple is an equal opportunity employer that is committed to inclusion and diversity. We seek to promote equal opportunity for all applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, Veteran status, or other legally protected characteristics. Learn more about your EEO rights as an applicant .
Submit Resume
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
Pay & Benefits
At Apple, base pay is one part of our total compensation package and is determined within a range. This provides the opportunity to progress as you grow and develop within a role. The base pay range for this role is between $174,900 and $291,400, and your base pay will depend on your skills, qualifications, experience, and location.
Apple employees also have the opportunity to become an Apple shareholder through participation in Apple’s discretionary employee stock programs. Apple employees are eligible for discretionary restricted stock unit awards, and can purchase Apple stock at a discount if voluntarily participating in Apple’s Employee Stock Purchase Plan. You’ll also receive benefits including: Comprehensive medical and dental coverage, retirement benefits, a range of discounted products and free services, and for formal education related to advancing your career at Apple, reimbursement for certain educational expenses - including tuition. Additionally, this role might be eligible for discretionary bonuses or commission payments as well as relocation. Learn more about Apple Benefits.
Note: Apple benefit, compensation and employee stock programs are subject to eligibility requirements and other terms of the applicable plan or program.
Apple is an equal opportunity employer that is committed to inclusion and diversity. We seek to promote equal opportunity for all applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, Veteran status, or other legally protected characteristics. Learn more about your EEO rights as an applicant .
Submit Resume
Salary : $174,900 - $291,400
