2. Principal Accountabilities: What are the key responsibilities of this job? List the what, how and why of each responsibility and provide examples, as necessary. Use specific verbs of , such as “manages”, “operates”, “analyzes”, “designs”, etc. Indicate three to five accountabilities in descending order of importance and approximate % of time spent on each.
This position will be leading and driving following activities:

Complaint handling:
1.To work with overseas manufacture sites on establishing the process of complaint handling and quality improvement
2.To work with local commercial team on complaint initial investigation and improvement closely
3.Be responsible for complaint handled in a time manner
4.Monitor the s from complaint investigation implementation progress and give feedback in timely manner
5.Figure out complaint negative trends and work with local commercial team, supply chain, Technical Service and overseas manufacture sites closely to settle the issues in advance
6.Escalate the potential field corrective s on nonconformance of the products found and implement field corrective
7.Follow up the CAPAs triggered by customer complaints
8.Conduct the training to teams and members involved in the process of complaint handling continuously to improve the quality sense of local commercial team, especially complaint reporting related
9.Review and optimize the process of complaint handling and work out the improvement plan and implement it
Adverse Event Handling and Management
1.Initial judgment on the reportable AE
2.Organize the cross-functional teams to work out proper report
3.Ensure all adverse events including local and oversea AE reporting are handled in timely manner and comply with requirement of regulation
4.Perform the communication with the Competent Authority.
Recall & FCA management
1. Work out the communication material for recall
2. Lead the cross-functional team to handle all the recalls in timely manner
3. Perform the communication with the Competent Authority and work out the report by the requirement of regulation.

Other tasks assigned by line manager.
3. Experience: What unique knowledge are needed to successfully perform the job and what would you consider most skills are most desirable (e.g., sales experience, ability to operate within a marketplace that is complex, management skills etc), years of experience.
?Health care industry 5+ years complaint handling, AE reporting and field corrective handling experience, in which 2+ year experiences in handling MD/IVD field corrective
?Strong knowledge on CFDA medical device regulations on complaint handling, AE reporting and field corrective .
?Seasoned communicator with business and regulators
?Strong problem & conflict solving capability on post market quality activities.
?Capable to drive business team’s post market quality awareness by training on MD post market regulations, etc.
4. Education (specific educational requirement or technical training, multi-language, Global, computer knowledge, etc)
?The candidate should have a Bachelor’s Degree in related life science or advanced technical degree or equivalent.
5. Job Competencies: What competencies are needed to successfully perform the job (business Acumen, Negotiation Skills, etc)
?Prior knowledge and understanding of the Medical Device/IVD or equivalent regulated industry
?The ability to lead a cross-functional team is required.
?Good discovery, analysis and problem solving skills
?High responsibility, passion and self-motivation
?Result-oriented
?Have the consciousness of quality first and persist quality maxim
?Fluent oral and written English

About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of more than $20 billion and approximately 65,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics, deliver medicines to market and increase laboratory productivity. Through our premier brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services – we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive services. For more information, please visit www.thermofisher.com.