Assistant Manager overseeing Compliance operations for Southeast Asia - based FinTech company. Engaging in regulatory alignment and policy implementation across several locations.
TK
Hybrid Regulatory Affairs Manager – Medical Device
Posted 5 months ago
About the role
- Regulatory Affairs Manager ensuring compliance for medical devices in Tübingen, Germany. Overseeing technical documentation and regulatory strategies for medical device approval with hybrid work arrangement.
Responsibilities
- Prepare and update technical documentation for medical devices in accordance with MDR 2017/745
- Ensure compliance with applicable regulatory requirements
- Develop test plans, organize testing activities, and define test parameters and equipment
- Create standardized test reports to demonstrate compliance with relevant standards
- Serve as the primary contact for notified bodies during technical documentation reviews and for regulatory inquiries from development and production teams
- Define regulatory strategies for the approval of medical devices
Requirements
- Completed degree in engineering or natural sciences
- Professional experience in Regulatory Affairs for medical devices
- Knowledge of ISO 13485 and MDR
- Excellent German (C1) and English skills, both written and spoken
- Strong coordination and organizational skills
Benefits
- New career perspectives and comprehensive guidance for your Regulatory Affairs career
- Positions that match your skills, expertise, and goals
- Exclusive job opportunities with company background information
- Optimization of your application documents and thorough interview preparation
- Direct access to decision-makers and support in negotiating the best compensation package
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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