Regulatory Affairs Supervisor,Shanghai
Solventum(5 months ago)
About this role
Solventum is hiring a Regulatory Affairs Supervisor to lead medical device registration activities and ongoing post-market registration upkeep. The role focuses on overseeing regulatory strategy and timelines for domestic medical devices and ensuring ongoing compliance for existing product licenses and labeling. The position partners with internal teams and interfaces with external regulatory bodies and testing institutions.
Required Skills
- Regulatory Strategy
- Medical Device Registration
- Regulatory Submissions
- Post-Market Compliance
- Labeling Compliance
- IFU Review
- Change Control
- License Renewals
- ISO 13485
- Audit Support
+5 more
Qualifications
- Bachelor’s Degree
- Master’s Degree
- ISO 13485 Internal Auditor Certification
About Solventum
solventum.comSolventum is a healthcare company focused on enhancing the quality of life through innovative solutions. With a legacy rooted in transformative healthcare practices, Solventum is dedicated to providing smarter and safer healthcare options for patients and providers alike. The company leverages advanced technology to improve healthcare delivery, ensuring that its services are efficient, reliable, and accessible.
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