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Apple Principle Regulatory Affairs Associate China, Beijing, Beijing 267770488
18.02.2025
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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:- Developing submission strategy for assigned product(s)- Collaborate with subject matter experts to draft submission documents (e.g. Product Technical Requirements document, Clinical Evaluation Report, etc)- Lead in country medical device type testing- Oversee submission review progress- Lead technical discussions with the regulatory agency and the test lab
Minimum Qualifications
- Bachelor's degree or equivalent in science or engineering.
- 7+ years experience in regulatory affairs.
- Fluent in both English and Chinese
Preferred Qualifications
- Masters / PhD / post-secondary education preferred.
- Experience working with the SaMD product or 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.
- Apple is an Equal Opportunity Employer that is committed to inclusion and diversity. We also take affirmative action to offer employment and advancement opportunities to all applicants, including minorities, women, protected veterans, and individuals with disabilities. Apple will not discriminate or retaliate against applicants who inquire about, disclose, or discuss their compensation or that of other applicants.
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