Posted 22 days ago
Regulatory Compliance & Safety Officer
AI Summary
Regulatory Compliance & Safety Officer responsible for implementing and monitoring safety, quality, and ESG policies; conducting internal audits; managing medical product registration and recall; and coordinating accident investigation and preventive actions in a healthcare setting.
About this role
Since 1987, Celki VitalAire has been a leading provider of respiratory care (oxygen therapy, ventilation and sleep apnea treatment), diabetes care and breastfeeding solutions to medical professionals and patients in Hong Kong and Macau. Celki VitalAire has become a part of Air Liquide since 2007 and employs over 120 employees that serve over 12,000 patients and healthcare professionals in the region.
How will you CONTRIBUTE and GROW?
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
Are you a MATCH?
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
About Air Liquide
A world leader in gases, technologies and services for Industry and Health, Air Liquide is present in 78 countries with approximately 64,500 employees and serves more than 3.8 million customers and patients. Oxygen, nitrogen and hydrogen are essential small molecules for life, matter and energy. They embody Air Liquide’s scientific territory and have been at the core of the company’s activities since its creation in 1902.
Our Differences Make Our Performance
At Air Liquide, we are committed to build a diverse and inclusive workplace that embraces the diversity of our employees, our customers, patients, community stakeholders and cultures across the world.
We welcome and consider applications from all qualified applicants, regardless of their background. We strongly believe a diverse organization opens up opportunities for people to express their talent, both individually and collectively and it helps foster our ability to innovate by living our fundamentals, acting for our success and creating an engaging environment in a changing world.
Skills
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