Principal Specialist, Commercial QARA
Cepheid(1 month ago)
About this role
The Principal Specialist, Commercial RAQA at Radiometer (a Danaher company) is a senior quality and regulatory leader based in Tokyo within the Danaher Dx Commercial QRA Center of Excellence. The role represents Radiometer Japan as the legal Soseki/MAH and ensures alignment with Japanese regulations and global quality standards to support in vitro diagnostics and patient care. The position works closely with global R&D and manufacturing stakeholders to maintain and improve the company’s quality and compliance posture.
Required Skills
- Regulatory Affairs
- Quality Assurance
- ISO 13485
- QMS
- CAPA
- Vigilance
- Complaint Handling
- Risk Management
- Inspection Readiness
- Team Management
+2 more
Qualifications
- Bachelor's or Master's in Pharmacy, Chemistry or Related Field
- Pharmacist License
About Cepheid
cepheid.comCepheid is delivering a better way to improve patient outcomes by enabling access to molecular diagnostic testing everywhere.
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