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