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) Assistant Project Manager , located in Shanghai, Shanghai, China.
This role leads and delivers cross-functional Quality, Regulatory, and Compliance projects supporting China Operations and Distribution within QARA International. This role ensures projects are planned, executed, and delivered on time, within scope and budget, and in compliance with internal quality systems and external regulatory requirements. This position plays a critical role in enabling compliant market access, distribution continuity, and operational excellence for DePuy Synthes in China.
Key Responsibilities
• Plan, organize, and control QARA projects supporting China commercial, operations, distributor and health authority requests, ensuring adherence to scope, timelines, budgets and quality compliance.
• Develop and maintain detailed project plans, schedules, risk registers, and communication plans; proactively manage dependencies and risks.
• Lead the cases related to post market collaboration project requested by health authorities, which includes but not limited to: Investigation assistance from the Drug Administration or the Market Supervision Bureau, Sampling and etc.
• Promote China GSP related policy shaping via connection with internal experts, industry experts and associations etc. Accelerate post market excellence management in China
• Coordinated process optimization within QARA organization and support commercial projects with cross-functional department as quality expert.
Qualifications
Education
• Bachelor’s degree required (e.g., Engineering, Life Sciences, Quality, Regulatory Affairs, or Business).
• Advanced degree (e.g., Master’s or MBA) preferred.
Experience and Skills
Required
• Typically 6–8 years of relevant work experience in Quality project or program management within regulated environments (medical devices, pharmaceuticals, or
healthcare preferred).
• Demonstrated experience managing cross-functional projects from planning through execution and closure.
• Strong coordination and communication skills
• Proven ability to manage schedules risks, and stakeholder expectations simultaneously.
• Can be adapted to the changing environment and work under challenges.
Preferred
• Experience supporting China operations and/or distributor-based business models.
• Experience coordinating external partners or vendors within project frameworks.
• Familiarity with GSP or ISO-based quality systems and regulatory expectations for medical devices.
• Certified Lead auditor is preferred.
• Strong communication and influencing skills across functions and seniority levels.
Other
• Languages: Fluent in Mandarin and English (written and spoken).
• Travel: Limited domestic travel within China; limited international travel as needed.
• Certifications: Project Management certification preferred (not required).
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit 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 Writing, Coaching, Collaboration, Communication, Legal Support, Problem Solving, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Regulatory Reporting, Risk Assessments, Strategic Thinking