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CONFIDENTIAL
Jr. Manager GRA Medical Devices – Hospital Care
Your main tasks:
- Preparation and planning of variation notifications based on the Change Control System in Document Management System in co-operation with the Global Regulatory Affairs departments.
- Evaluation of impact of changes in relation to international registration status in co-operation with international local Regulatory Affairs Departments and documentation in corresponding databases & tools.
- Preparation of respective documentation to support change notifications at competent authorities and local Regulatory Affairs organizations.
- Tracking and update of international registration status with respective tools and databases.
- Tracking of regulations in countries from aria of responsibility
- Registration of new products and execution of re-registrations in international countries in co-operation with the Global Regulatory Affairs Department.
- Update labelling requirements and support for labelling updates according to the identified requirements.
- Preparation of documentation for customer specific request (tender etc.) in co-operation with Global Regulatory Affairs
- Maintenance of regulatory documentation
- Preparation of declarations in co-operation with Global Regulatory Affairs
- Supports task forces and specific Regulatory Affairs related projects
- Assure lessons-learned procedures
- Safeguarding/Adherence of Compliance Regulation “Code of Conduct“
Your profile:
- University degree in pharmacy, chemistry, biochemistry, biology, medicine, bioengineering, or medical engineering,
- Fluency in English (written and verbal); German is an advantage,
- Good computer skills (MS Office, Adobe Professional, Outlook, SAP is an advantage)
- Organized with good communication skills
- Willing to travel internationally
- Team work skills