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. ","responsibilities":"In this key role of the Post Market Surveillance Specialist:
Be responsible for all administrative activities associated with the complaint handling process including, but not limited to, reviewing, managing and closing complaints records in the complaint handling system.
Work with cross functional teams such as clinical, engineering and customer service groups to ensure product investigations are completed as well as maintain ongoing tracking and trending of complaints.
Evaluate post market data and update risk management documentation
Evaluate complaint documentation for completeness and consistency, and execute additional actions as necessary to close the complaint file.
Submit timely Adverse Event Reports to regulatory agencies, when appropriate
Conduct Post Market Surveillance activities to analyze post-market quality issues and trends
Identify potential issues to continuously improve product safety
Serve as the Subject Matter Expert to the Company for Complaints and Post Market Surveillance
Assist in the preparation and sending of post-market reports and submissions
Assist in different project work and process improvements as needed
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
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
