Associated Regulatory Affairs Manager
HybridSuzhou, Jiangsu, China
Job Summary
Collaborate with regulatory and cross-functional SMEs to implement comprehensive regulatory strategies for smaller, less complex projects. Apply analytical skills to resolve efficiency requests by exercising judgment within defined procedures for conformity assessment and submission documentation. Coordinate product/solution licensing submissions, manage device update files, and support tender-related issues with the Marketing Team. Review product labeling and marketing communications to ensure compliance with guidelines, while advising cross-functional teams on regulatory standards. Maintain processes for regulatory filings and licenses, participate in process improvement activities, and disseminate applicable requirements to relevant sites.
Required Qualifications
- Bachelor's Degree / Vocational Education in Biomedical Engineering, Business Administration, Health Sciences, Pharmaceutical, Law or equivalent
- No prior experience required with Bachelor's Degree OR minimum 4 years of experience with Vocational Education in Regulatory Affairs, Quality Compliance, Product Development in Medical Devices Industry or equivalent
- Minimum required Education: Bachelor's Degree / Vocational Education in Biomedical Engineering, Business Administration, Health Sciences, Pharmaceutical, Law or equivalent
- Minimum required Experience: No prior experience required with Bachelor's Degree OR minimum 4 years of experience with Vocational Education in Regulatory Affairs, Quality Compliance, Product Development in Medical Devices Industry or equivalent
- For our office-based teams, this means working in-person at least 3 days per week
- Onsite roles require full-time presence in the company's facilities
Desired Qualifications
- Preferred Certification: RAPS RAC certification
- Regulatory Requirements
- Document Auditing
- Data Management
- Administrative Support
- Product Registrations
- Product Labeling
- Strategy Implementation
- Stakeholder Management
- Regulatory Submission Documentation
- Conformity Assessment
- Regulatory Intelligence
- Continuous Improvement
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