Post Market Specialist - Health China at Apple

Shanghai, Shanghai, China -

Full Time

Start Date

Immediate

Expiry Date

22 Jun, 26

Salary

0.0

Posted On

24 Mar, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Management Systems, Communication, Customer Service, Interpersonal Skills, Attention To Detail, Organization, Time Efficiency, Multi-tasking, Regulatory Requirements, Technical Writing, English Proficiency, Regulatory Audits, CAPA, Complaint Handling, Field Action, Adverse Event Reports

Industry

Computers and Electronics Manufacturing

Description

Apple is where individual imaginations gather together, committing to the values that lead to great work. Every new product we build, service we create, or Apple Store experience we deliver is the result of us making each other’s ideas stronger. That happens because every one of us shares a belief that we can make something wonderful and share it with the world, changing lives for the better. It’s the diversity of our people and their thinking that inspires the innovation that runs through everything we do. When we bring everybody in, we can do the best work of our lives. Here, you’ll do more than join something — you’ll add something. 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 Post Market Surveillance Specialist to support complaint handling and related post market activities in China for regulated features. 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 The Post Market Surveillance Specialist is part of the post market surveillance (PMS) team supporting Apple’s medical products. The post market team is responsible for performing the domestic and international product surveillance activities. MINIMUM QUALIFICATIONS Extensive experience in managing, maintaining and implementing quality management systems Excellent written and verbal communication skills Strong customer service orientation and corresponding skills Excellent interpersonal skills working across multiple divisions Attention to detail, well organized and time efficient Can multi-task and work independently Knowledge of domestic medical device regulatory requirements (China GMP) Technical writing skills Proficient in English both oral and written Experience leading and managing regulatory audits BS/MS degree in Engineering, Math, Statistics, science-related field, or equivalent technical experience 3+ years of direct work experience in medical device quality functions, CAPA, complaint handling, or field action is preferred. Thorough knowledge of domestic medical device regulatory requirements (China GMP) Direct experience with receiving, evaluating, and investigating complaints Direct experience with submitting Adverse Event Reports Experience developing and implementing post market processes for new product development activities Proficiency in utilizing IMDRF codes and a comprehensive clinical grasp of handling complaints PREFERRED QUALIFICATIONS Ability to take initiative in an ambiguous and fast fast paced environment Excellent verbal and written communication skills with ability to lead meetings Strong organizational, time management, and influence skills Experience with risk management is highly preferred Experience with high volume complaints environment Knowledge of international medical device regulatory requirements

Responsibilities

The Post Market Surveillance Specialist supports complaint handling and related post-market activities in China for regulated health features within Apple's medical products group. This role involves performing domestic and international product surveillance activities as part of the post-market surveillance team.