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Your main tasks:
- Preparation and planning of variation notifications based on the Change Control System in SAP 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 SAP & system.
- 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
- Registration of new products and execution of re-registrations in international countries in co-operation with the Global Regulatory Affairs Department.
- Supports task forces and specific Regulatory Affairs related projects
- Assure lessons-learned procedures
- Maintenance of Regulatory Documentation
- Preparation of declarations in co-operation with Global Regulatory Affairs
- Preparation of documentation for customer specific request (tender etc.) in co-operation with Global Regulatory Affairs
- Safeguarding/Adherence of Compliance Regulation “Code of Conduct“
Your profile:
- University degree in medical engineering, bioengineering, chemistry, biochemistry or medicine,
- Fluency in English (written and verbal); German is an advantage,
- Good computer skills (MS Office, SAP, Adobe Profesional)
- Organized with good communication skills
- Willing to travel internationally
- Team work skills
Become part of a corporate culture that actively promotes constructive exchanges between colleagues, customers and partners. Work with us to improve people's lives in the long term. We can offer you interesting, varied tasks and excellent opportunities foradvancement, as well as an attractive salaryandbenefits, all within a dynamic family-owned company.