Description
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Job Function:
Regulatory Affairs GroupJob Sub Function:
Regulatory AffairsJob Category:
ProfessionalAll Job Posting Locations:
Shanghai, ChinaJob Description:
DePuy Synthes is recruiting for a(n) Sr. Quality Engineer, located in Shanghai, Shanghai, China.
This role supports China operations and distributor management activities within Quality & Regulatory Affairs (QARA), ensuring compliant, efficient, and reliable execution of operational and distribution processes. This role partners closely with internal cross‑functional teams and external distributors to maintain regulatory compliance, support product availability, and drive continuous improvement across China distribution operations. This position plays a critical role in protecting patients, customers, and the DePuy Synthes brand while supporting business growth in a complex regulatory environment.
Key Responsibilities
Lead complaint/Potential Adverse Event /suspected diversion or counterfeit case/Legal case management.
Act as contact window between global and local operation company, implement Product Recall activities to compliance with China regulatory, company policy and Local quality management system requirements.
Work together with global PMS to complete vigilance related reports per China regulation and company requirements, including but not limit to periodic risk evaluation reports (PRER), risk signal report and etc.
Responsible for special monitoring program, risk evaluation report, VBP report, adverse events from Health Authority system directly.
Support on AE investigation to ensure compliance related to government/health authority regulations.
Support regulatory and quality audits, inspections.
Identify and support continuous improvement initiatives to enhance PMS efficiency and compliance.
Qualifications
Education
Bachelor’s degree required, preferably in Life Sciences, Engineering, Supply Chain, Quality, Regulatory Affairs, or a related field.
Advanced degree preferred (e.g., Master’s).
Experience and Skills
Required:
Typically 4–6 years of relevant professional experience in Quality, Regulatory Affairs, Operations, Supply Chain, or Distribution Management within a regulated industry (e.g., medical devices, pharmaceuticals, healthcare).
Working knowledge of China regulatory and quality requirements related to product distribution and post market surveillance.
Ability to work effectively in a matrixed, cross‑functional environment.
Preferred:
Experience supporting QARA or compliance‑driven operations within a global organization.
Familiarity with audits, inspections, CAPA, and continuous improvement methodologies.
Experience working with global or regional stakeholders across time zones.
Hold a certificate in adverse event reporting training
Strong analytical, documentation, and problem‑solving skills.
Other:
Language: Fluency in Mandarin and English required.
Travel: Limited; Up to 10–20%, primarily within China.
Certifications: Quality or Regulatory certifications (e.g., ISO, internal auditor) preferred but not required.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit https://www.careers.jnj.com.
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:
Analytical Reasoning, Business Behavior, Business Writing, Communication, Confidentiality, Data Reporting, Detail-Oriented, Legal Support, Medicines and Device Development and Regulation, Problem Solving, Product Licensing, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Teamwork