Head of China Regulatory Affairs

We care deeply about getting amazing new products into our customers hands.

Description
You will lead 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. - Monitor and assess regulation changes, and partner with other Apple teams to shape regulations and guidances as necessary.

Preferred Qualifications

Masters / PhD / post-secondary education preferred.
Extensive regulatory experience in China, including significant experience in leading interactions with regulatory authorities.
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.

Minimum Qualifications
Bachelor's degree or equivalent in science or engineering.
10+ years experience in regulatory affairs.
Fluent in both English and Chinese

Apple is an equal opportunity employer that is committed to inclusion and diversity, and thus we treat all applicants fairly and equally. Apple is committed to working with and providing reasonable accommodation to applicants with physical and mental disabilities.