Our client is a global diagnostics company and is currently on the lookout for an APAC RAQA (Regulatory Affairs and Quality Assurance) Manager to join their team based in Singapore. This permanent position offers a unique opportunity to steer regulatory strategies across Asia-Pacific markets while ensuring top-notch quality assurance practices.
Key Responsibilities:
- Lead communication with various regional regulatory authorities.
- Oversee implementation and maintenance of robust QMS frameworks.
- Lead regulatory strategies for local submissions and registration, QMS setup/maintenance and Post Market compliance
- Work with cross functional teams internally for regulatory and QMS assessments.
- Drive compliance with diagnostic industry standards throughout APAC territories.
Essential Skills Required:
- Bachelor's degree
- At least 5 years of experience in RA in medical device/IVD industry
- Extensive experience managing Quality Management Systems
- Good communication, organisation and negotiation skills
If you are interested, please apply with your CV attached.