
OUS China Regulatory Affairs Specialist - Health
Attention all regulatory affairs professionals! Are you passionate about utilizing your expertise in the health industry to make a positive impact on people's lives? Do you have a strong understanding of China's regulatory landscape and experience navigating its complex requirements? If so, Apple wants you to join our team as an OUS China Regulatory Affairs Specialist - Health. In this role, you will play a critical role in ensuring our products meet all necessary regulatory standards in China, allowing us to continue providing innovative and life-changing health solutions to our customers. We are looking for a highly qualified individual with a personal drive for excellence and a deep understanding of regulatory affairs in the health sector. If you are ready to be a part of a dynamic and innovative team at Apple, read on to learn more about this exciting opportunity.
- Develop and maintain a thorough understanding of China's regulatory landscape and requirements for health products.
- Monitor and analyze regulatory changes and updates in China to ensure compliance with all necessary standards.
- Collaborate with cross-functional teams to ensure that all health products meet regulatory requirements in China.
- Prepare and submit regulatory filings and documentation to relevant authorities in a timely and accurate manner.
- Stay informed about industry trends and best practices in China's regulatory environment and make recommendations for improvement.
- Act as a liaison with regulatory authorities in China and represent Apple at meetings and conferences.
- Provide guidance and support to internal teams on regulatory matters related to health products in China.
- Conduct internal audits and assessments to ensure compliance with regulatory standards and identify areas for improvement.
- Develop and maintain relationships with key stakeholders in China's health industry.
- Train and educate team members on regulatory requirements and updates in China to ensure understanding and adherence.
- Continuously review and update processes and procedures to ensure alignment with China's regulatory requirements.
- Maintain accurate and organized records of all regulatory activities and submissions.
Bachelor's Degree In A Relevant Field Such As Regulatory Affairs, Public Health, Or Biomedical Sciences.
Minimum Of 3 Years Of Experience In Regulatory Affairs Within The Healthcare Industry, Preferably With A Focus On China.
Proficiency In Chinese Language And Understanding Of Chinese Regulatory Processes And Requirements.
Strong Understanding Of Global Regulatory Guidelines And Standards, Including Fda And Cfda Regulations.
Excellent Communication And Interpersonal Skills, With The Ability To Work Effectively With Cross-Functional Teams And External Stakeholders.
Market Research
Quality Management
Government Relations
Regulatory compliance
Cross-Cultural Communication
Medical Devices
Product Registration
Regulatory Strategy
Pharmaceutical Industry
Product Safety
Chinese Regulations
Communication
Conflict Resolution
Customer Service
Emotional Intelligence
Leadership
Time management
creativity
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a OUS China Regulatory Affairs Specialist - Health in Cupertino, CA, USA is $122,687 - $163,583 per year. This salary range can vary depending on factors such as level of experience, education, and specific job responsibilities.
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Apple, Inc. engages in the design, manufacture, and marketing of mobile communication, media devices, personal computers, and portable digital music players. It operates through the following geographical segments: Americas, Europe, Greater China, Japan, and Rest of Asia Pacific. The Americas segment includes both North and South America. The Europe segment consists of European countries, as well as India, the Middle East, and Africa. The Greater China segment comprises of China, Hong Kong, and Taiwan.

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