OUS APAC Regulatory Affairs Lead

at  Apple

SUMMARY

Posted: Aug 29, 2024
Weekly Hours: 40
Role Number:200565022
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 Regulatory Affairs Lead to over see all regulated health features in the APAC region. 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 regulatory affairs activities in all APAC markets 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. • Communicate and align regulatory plans with internal Apple teams. • Lead regulatory authority discussions within APAC. • Monitor and assess regulation changes, and partner with other Apple teams to shape regulations and guidances, as necessary.

• Bachelor’s degree or equivalent in life sciences or engineering.
• 5+ years confirmed experience in regulatory affairs / regulatory compliance.
• Significant experience in leading interactions with regulatory authorities across the APAC region.

PREFERRED QUALIFICATIONS

• Masters / PhD / post-secondary education preferred.
• Experience working with the SaMD product and wearable technology.
• Extensive experience in key APAC markets (e.g. China, Japan).
• 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.
• Proficient in Mandarin Chinese

• Bachelor’s degree or equivalent in life sciences or engineering.
• 5+ years confirmed experience in regulatory affairs / regulatory compliance.
• Significant experience in leading interactions with regulatory authorities across the APAC region