ComplaintPRE Specialist, China

DePuy Synthes is recruiting for a(n) Complaint/PRE Specialist China Commercial Qualitylocatedin Shanghai Shanghai

Job Overview

The Complaint/PRE Specialist Chinais responsible forsupporting complaint handling and product reportable event (PRE) activities within Commercial Quality. This role ensurestimelyaccurate and compliant processing of customer complaints and product event datain accordance withregulatory requirements and internal quality system standards. The position plays a critical role in safeguarding patient safety supporting regulatory compliance and enabling effective postmarket surveillance in the China market.

Key Responsibilities

• Receive assess document and process customer complaints and product reportable events (PREs)in accordance withinternal procedures and regulatory requirements.

• Ensuretimelyescalationinvestigationcoordination and closure of complaints andPREs.

• Support postmarket surveillance and vigilance activities including adverse event reporting as.

• Partner with Commercial Regulatory Affairs Quality and Supply Chain teams to support compliant postmarket processes.

• Maintainaccurateand complete documentation and records within complaint and PRE management systems.

• Support internal audits external audits and healthauthorityinspections related to complaints and postmarket activities.

• Monitorcomplaintand PRE trends and support corrective and preventive action activities.

• Contribute to continuous improvement initiatives to enhance complaint handling efficiency and compliance.

Qualifications

Education:

• Bachelors degree in Quality Engineering Life Sciences Regulatory Affairs ora relateddiscipline (required).

• Advanced degree in a scientific or regulatory field (preferred).

Experience and Skills:

Required:

• Typically0-2 years of experience in Quality Regulatory or Compliance roles within a regulated industry.

• Experience supporting complaint handling product event reporting or postmarket 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 crossfunctional collaboration skills.

Other:

• Language: Mandarin; Englishproficiencypreferred.

• Travel: Limited; occasional domestic travel within China.

• Certifications: Quality or Regulatory certifications preferred but not.