Beschreibung
Regulatory Affairs Manager (m/f/d)
Reference: -en
Start: asap
Duration: 12 MM+
Main tasks:
- Manage the regulatory activities and support the product care activities of the assigned (existing and authorized) product portfolio within SIS Workflow and IT Software/Hardware Projects, No Assays
- Assess and communicates regulatory risks and challenges to project teams and Interfaces with the lifecycle team (no direct contact with the regulatory authorities)
- Consultancy and active support of the R&D project teams during the development of new products and during the product lifecycle
- Accomplish conformity evaluation for new and existing devices (also under the IVDR)
- Planning of Deliverables with other Regulatory Affairs professionals for product registrations, including compilation of corresponding Software- and Hardware-Reports
- Provide insights into upcoming regulatory changes and trends prior to the issuance of new guidance, standards, laws, or regulations (MDR/IVDR)
- Work in a cross-functional, multi-site team to ensure alignment and harmonization
Main qualifications
- Profound experience as Regulatory Affairs Manager in electrical medical
- Experience witj devices and/or IVD Instruments
- Experience with Development of Hardware and Software of IVD Instruments preferred
- Mechanical/Electrical Expertise
- Fluency in English
Main advantages:
- A highly motivated team and an open way of communication
- Interesting tasks in a multinational environment
- Possibilities to work in a home office
About us:
With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
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