Apple – Head of China Regulatory Affairs 职位分析和面试指导

职位描述：

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 Head of Regulatory Affairs to oversee all regulated health 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 multiple functional teams. 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.

职位要求：

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

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.

招聘部门：

Apple Corporate Functions

工作地点：

Beijing, Beijing, China

面试建议：

Apple正在寻找一位Head of China Regulatory Affairs来负责中国区的医疗设备法规事务。这个职位不仅要求深厚的法规事务经验，还需要能够与监管机构有效沟通，并制定清晰的法规策略。对于应聘者来说，这是一个既充满挑战又极具影响力的职位。 在准备面试时，你需要重点展示你在中国法规事务方面的专业知识和经验。特别是你与监管机构的互动经验，以及你在SaMD和可穿戴技术领域的背景。面试官可能会深入询问你如何处理复杂的法规挑战，以及你如何制定和执行法规策略。此外，你的沟通能力和独立工作能力也是面试的重点。建议你准备一些具体的案例，展示你如何在过去的职位中成功应对法规挑战，并与监管机构建立良好的关系。