QARA Manager, Greater China
MolnlyckeShanghai, China
Posted January 22, 2026
Full Time
About the Company
Mölnlycke is a world-leading medical solutions company that designs and supplies solutions to enhance performance at every point of care.
Job Description
Mölnlycke is seeking a QARA Manager to lead the regional Quality and Regulatory Affairs strategy in Greater China. The role will drive implementation of regulatory updates, develop a sustainable RA and product registration roadmap, and ensure compliance with standards.
Requirements
- Bachelor's degree in life-science or another relevant scientific discipline, or equivalent combination of experience and education.
- A minimum of 10 years within an international medical device company, working within QA and/or RA, preferably a minimum of 5 years in a leadership position.
- Deep understanding of regulatory requirements, including ISO 9001, ISO 13485, MDR, and regional standards.
- Extensive knowledge of China’s manufacturing regulatory environment, with a proven track record of ensuring full compliance in local operations.
- Excellent communication and proven ability to lead cross-functional teams and work with internal stakeholders.
- Good experience with regulatory authorities’ inspections.
- Fluent in English and Chinese and used to work in a multicultural environment.