Are you a detail-oriented quality and compliance professional looking to make a meaningful impact? We are seeking a dedicated Regulatory Compliance & Safety Officer to oversee our quality management systems, ensure regulatory excellence, and foster a robust culture of safety and health across our operations.

Key Responsibilities

• Safety & Security Compliance

  • Implementation of the Group’s/Company’s industrial management system, quality management system, and safety & health & ESG policies and procedures and regular reporting

  • Monitor regularly the staff compliance on the Safety & Security rules and carry out internal quality and safety check and audits

  • Develop and conduct training & campaign to staff and coach all staff to develop further awareness on health & safety work practices

• Medical Product Registration and Accident Investigation and Prevention

  • Manage product registration & recall management according to regulatory and legal requirements

  • Monitor and coordinate any accident investigation and proactively introduce preventive action

• Quality System & Audit Management

  • Conduct internal audit periodically and communication of audit findings to the relevant personnel for action

  • Ensure the Company’s quality system is properly implemented in accordance with ISO 9001:2015 and liaise with external parties on matters relating to the improvement the ISO system

  • Manage and improve ISO based Quality Management System documentation according to the group’s guidelines and maintain proper quality records

Requirements

• Degree holder in Quality / Biomedical Engineering / Pharmaceutical Science / Safety Management or related disciplines

• 2 to 3 years solid experience in ISO Quality Management System; preferably with experience in healthcare industry

• Solid experience in handling medical device/pharmaceutical regulatory/GMP and product recall

• A certified internal auditor with experience in managing ISO internal audit is preferred

• Good planning, organization and project management skills

• Strong research, analytical, interpersonal and communication skills

• Good team player and able to work independently under tight deadlines

• Fluent English and Chinese with strong computer skills

• Immediate available is highly preferred

We offer a competitive remuneration to the right candidate. Interested parties please send us full resume stating current and expected salary and available date by clicking the button of Quick Apply for job application.

Please visit our website: http://www.celki.com for further information of our Company.

Data collected will be used for recruitment purpose only.