OUS Regulatory Affairs Specialist @ Apple

Summary

Our ever-evolving suite of Heath and Wellness products for iPhone and Watch are 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. The same dedication to innovation also applies to our business practices -strengthening our commitment to leave the world better than we found it. The  Health group is looking for a Principal Regulatory Affair Associate to support regulated features in China. 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 organization who works closely together to establish relationships across multi-functional teams. We care deeply about getting amazing new products into our customers hands.

Minimum Qualifications

Bachelor’s degree or equivalent in life sciences or engineering.
5+ years experience in regulatory affairs / regulatory compliance.
Significant experience in leading interactions with regulatory authorities in China

Preferred Qualifications

Masters / PhD / post-secondary education preferred.
Experience working with the SaMD product and wearable technology.
Executive poise and presence, including a track record of positively influencing decisions and teams.
Demonstrable background in being autonomous and being able to clearly work towards establish goals and initiatives with minimal oversight.
Excellent communication skills, both verbal and written.
Proficient in Mandarin Chinese

Description

You will be responsible for medical device regulatory affairs activities in China for Apple Health. You will demonstrate the ability to develop a variety of solutions to RA/QA challenges and will exercise independent judgment in settling and communicating appropriate regulator action and engagement strategy. Key responsibilities include: - Develop and execute clear regulatory strategies for Apple Health features in China. - Communicate and align regulatory plans with internal Apple teams. - Lead regulatory authority discussions in China. - Monitor and assess regulation changes, and partner with other Apple teams to shape regulations and guidances as necessary.

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 $140,700 and $234,700, 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.

OUS Regulatory Affairs Specialist

Health

Apple

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