Regulatory Affairs Manager – Medical Device
TRIGA Consulting GmbH & Co. KG
full-time
Posted on:
Location Type: Hybrid
Location: Tübingen • 🇩🇪 Germany
Visit company websiteJob Level
Mid-LevelSenior
About the role
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
technical documentationtest planstesting activitiestest parameterstest reports
Soft skills
coordination skillsorganizational skillscommunication skills
Certifications
degree in engineeringdegree in natural sciences