Description
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Job Function:
QualityJob Sub Function:
Customer/Commercial QualityJob Category:
ProfessionalAll Job Posting Locations:
Shanghai, ChinaJob Description:
DePuy Synthes is recruiting for a(n) Complaint/PRE Specialist, China – Commercial Quality, located in Shanghai, Shanghai
Job Overview
The Complaint/PRE Specialist, China is responsible for supporting complaint handling and product reportable event (PRE) activities within Commercial Quality. This role ensures timely, accurate, and compliant processing of customer complaints and product event data in accordance with regulatory requirements and internal quality system standards. The position plays a critical role in safeguarding patient safety, supporting regulatory compliance, and enabling effective post‑market surveillance in the China market.
Key Responsibilities
Receive, assess, document, and process customer complaints and product reportable events (PREs) in accordance with internal procedures and regulatory requirements.
Ensure timely escalation, investigation coordination, and closure of complaints and PREs.
Support post‑market surveillance and vigilance activities, including adverse event reporting as required.
Partner with Commercial, Regulatory Affairs, Quality, and Supply Chain teams to support compliant post‑market processes.
Maintain accurate and complete documentation and records within complaint and PRE management systems.
Support internal audits, external audits, and health authority inspections related to complaints and post‑market activities.
Monitor complaint and PRE trends and support corrective and preventive action activities.
Contribute to continuous improvement initiatives to enhance complaint handling efficiency and compliance.
Qualifications
Education:
Bachelor’s degree in Quality, Engineering, Life Sciences, Regulatory Affairs, or a related discipline (required).
Advanced degree in a scientific or regulatory field (preferred).
Experience and Skills:
Required:
Typically 0-2 years of experience in Quality, Regulatory, or Compliance roles within a regulated industry.
Experience supporting complaint handling, product event reporting, or post‑market surveillance activities.
Foundational understanding of quality system requirements and regulatory expectations for commercial operations.
Ability to interpret procedures and regulatory requirements and apply them accurately.
Preferred:
Experience in medical devices, healthcare, or other highly regulated industries.
Familiarity with China regulatory and vigilance requirements (e.g., NMPA expectations).
Experience supporting audits, inspections, or health authority interactions.
Experience working in a multinational or matrixed organization.
Quality or Regulatory certifications (e.g., RAC).
Strong attention to detail, documentation, and data accuracy.
Effective communication and cross‑functional collaboration skills.
Other:
Language: Mandarin required; English proficiency preferred.
Travel: Limited; occasional domestic travel within China.
Certifications: Quality or Regulatory certifications preferred but not required.
Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.
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Required Skills:
Preferred Skills:
Business Behavior, Compliance Management, Continuous Improvement, Data Analysis, Data Compilation, Detail-Oriented, Execution Focus, Goal Attainment, Internal Controls, Issue Escalation, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Report Writing