Complaint/PRE Specialist, China

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.

Requirements

• 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 is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orien

Benefits

Additional Information

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com . As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Quality Job Sub Function: Customer/Commercial Quality Job Category: Professional All Job Posting Locations: Shanghai, China Job 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.

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