Senior Regulatory Affairs Manager (Software Regulations)

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  1. Contract
  2. English, Spanish
  3. Mid-Senior level
  4. Research & Development
  5. Rotkreuz
  6. Healthcare & Life Sciences
  7. Regulatory Affairs, Medical Devices
Swisslinx, as the premier supplier to a leading Life Sciences company, is currently tasked with securing a Regulatory Affairs Manager with an international track record in Medical Devices. In this dynamic role, you will contribute to the development of a regulatory affairs strategies and execution as well as developing corresponding documentation.

This is a 12 month contract initially with the possibility of extension and is currently home based.

Your mission
- Manage regulatory initiatives and projects related to new and existing products
- Support R&D activities in needs of regulatory advisory
- Review labelling, administration of product declarations/certificates a maintain overview and create documentation
- Ensure all relevant stakeholders are aware of new regulatory developments and project progress
- Keep abreast for regulatory changes and provide training to team members

Your profile
- Minimum of 6 years of international regulatory affairs experience with a focus on medical devices
- Knowledge of vitro diagnostic medical devices would be a strong asset
- Relevant educational background in life sciences or engineering
- High level of cultural aware ness and strong communication skills
- Flexible, adaptable and focussed approach to work
- Maximum notice period is 2 months

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