Associate Manager Regulatory Affairs
Associate Manager Regulatory Affairs (m/w/d)
Original-Inserat anzeigenAssociate ManagerIN Regulatory Affairs (m/w/d)
We are looking for a highly qualified and motivated Associate Manager Regulatory Affairs to join our dynamic team in the medical device industry. In this position you will play a key role in the approval of our products in new countries, the submission and updating of all technical documentation and in the monitoring of standards.
What to expect
- Support in the creation and management of processes related to regulatory activities
- Support in the preparation of approval / technical documentation for our medical devices
- Collaboration on product approvals for medical devices and their maintenance
- Varied and cross-departmental collaboration on projects for the development of innovative medical devices on the structural heart field
- Monitoring the relevant regulatory intelligence by researching, summarizing, and evaluating regulatory requirements for medical devices as well as informing the appropriate stakeholders in the organization
- Close technical cooperation with internal departments (e.g. development department, project management, quality department) and contact with external partners
- Studies in the field of medical technology, natural sciences or technology
- Curiosity and passion in the field of medical technology
- Experience in the field of regulatory affairs (EU and RoW) – at least 3 years
- Knowledge of regulatory requirements for medical devices (e.g. MDR) or biological materials desirable
- Understanding the basics related to quality assurance, development, or clinical affairs of medical devices is an advantage
- Very good written and spoken English skills
- Structured, accurate and responsible way of working
What we offer:
- Good development opportunities through continuous growth
- Active involvement in shaping an expanding company
- Exciting and constantly growing product portfolio
zur Vakanz
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