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Regulatory Affairs

Staff Compliance Specialist

  • Job Title Staff Compliance Specialist
  • Function Regulatory Affairs
  • Sub Function Regulatory Compliance
  • Location Hangzhou, Zhejiang, China
  • Date Posted
  • Requisition Number 2206096500W
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Plan, coordinate, and conduct quality system audits of J&J Vision facilities and supportive activities for compliance as mandated by federal and international regulations and standards (e.g., FDA QSR, FDA cGMP, ISO, GCP) and Company requirements.  Facilities include worldwide operations, including the United States, Europe, and Asia. 

Provide support to the JJV segment in the performance of audits or audit related activity.

Provide regulatory assessments of audit findings and prepare appropriate reports to auditees and management following established procedures.

Review and monitor required corrective actions, conduct follow-up activities on required action items.

Assist in the preparation and presentation of regulatory compliance training materials for regulatory, quality, technical, and managerial personnel.

Providing support for FDA, Health Authority and Notified Body inspections conducted at J&J Vision locations, including readiness activities, front- and back-room participation/management and general inspection support as requested.  Serve as company representative during regulatory inspections.  Support activities may include actively and directly interacting with inspectors/auditors, obtaining required information, and assisting with corrective action and/or remediation plans, as necessary.

Consult with management, manufacturing, R&D, marketing company and laboratory staff to help formulate and implement proactive regulatory compliance strategies and controls.

Maintain a leadership presence with government regulators and external professional organizations in order to monitor and influence regulatory issues.

Develop and maintain key quality and compliance performance metrics.  Participate in developing and presenting departmental materials for Management Review and Annual Product Reviews.

Lead and/or participate on projects and initiatives, such as product design and development activities and operations/production initiatives, providing regulatory compliance guidance with regard to regulated products within the J&J Vision portfolio, including medical devices, API manufacturing, aseptic processing, combination products, and ophthalmic solutions.


Strong communication, organizational, negotiation and interpersonal skills.

Expert knowledge, understanding and application of audit principles, concepts and practices related to quality system regulated by domestic and foreign governments.

Understanding and knowledge of a broad set of regulations and standards (e.g. 21 CFR 820; 21 CFR 210/211; ISO 13485; ISO 9001; EU MDD/MDR; Australian Therapeutic Goods Regulations No. 236; Brazil GMP Regulations Resolution RDC n°16; CMDR – SOR98-282; Japan MHLW Ordinance No. 169; 21 CFR 50, 54, 56, 58; 21 CFR 812 and 814; ICH GCP Guidelines, MDSAP, etc.)

Knowledge of IT internal controls, software development lifecycle (SDLC) methodologies, data integrity requirements, as well as general knowledge of cybersecurity and Medical Device software is a preferred skill.

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