Regulatory Compliance Engineer

Beijing, Beijing, China
Hardware

Summary

Posted: 2018 年 11 月 6 日
Weekly Hours: 40
Role Number: 200008191
Imagine what you could do here. At Apple, new ideas have a way of becoming extraordinary products, services, and customer experiences very quickly. Bring passion and dedication to your job and there's no telling what you could accomplish. The people here at Apple don’t just build products - they build the kind of wonder that’s revolutionized entire industries. It’s the diversity of those people and their ideas that inspires the innovation that runs through everything we do, from amazing technology to industry-leading environmental efforts. We may expect you to be responsible for regulatory certification on products. You will contribute to interpret medical standards and medical regulation and take part in the conference for new medical standards and regulatory implementation. We expect you to be creative, well-organized, with phenomenal verbal and written communication.

Key Qualifications

  • We expect you to meet one of following options.
  • At least 5 years working experience in medical device registration & clinical management is helpful
  • Strong background for medical device. Be familiar with medical device supervision
  • Be familiar with medical related regulations and medical device registration
  • Proven planning skill
  • Abilities to work in multi-functional teams across multiple time zones.
  • Strong problem identification and issue resolution abilities and be able to investigate and debug complex issue investigations
  • Self motivation
  • Excellent communication and presentation skills in Mandarin and English

Description

Managed the device registration project, tracked the product registration progress in real time. To prepare registration documents and submit the registration materials. Responsible for the communication and coordination of registration affairs with the review organization, ensuring the smooth submission, review and approval of registration applications and the timely certification. Understand and study domestic and international laws and regulations for new product certification and registration. Working closely with multi-functional team to ensure certification accomplishment successfully on time.

Education & Experience

Bachelor or above degree in medical device, medicine, biology or related and Master degree is preferred.

Additional Requirements