Medidee Services is one of the leading international consulting services for medical devices and in vitro diagnostics (IVD). We provide practical support to manufacturers, competent authorities and public organizations in complying with applicable regulatory requirements. Our services cover the entire lifecycle of medical devices and IVDs, from design and development through clinical validation to regulatory approval and post-market surveillance.
With offices in Switzerland, Germany, Belgium, Denmark, APAC and the USA, Medidee Services is everywhere close to the client. We are looking for teammates with a background in Medical Device regulatory or quality affairs, willing to drive complex Medical Device projects in the framework of the current regulatory changes.
Your mission will be to:
• Provide strategic and hands on regulatory support to clients related to compliance (Reg.EU 2017/745, Reg.EU 2017/746, MDSAP, ISO13485)
• Assess complex scientific / technical documentation, to identify gaps and to provide support for improvement
• Manage projects in a structured way in direct contact with Clients, Competent Authorities and Notified Bodies - during audits, conformity assessments and with product specific regulatory issues
• Coach clients on implementation and remediation activities for QMS, technical documentation
• Assist clients in successfully managing nonconformities, complaints, recalls, FSN, FSCA
• Participate in the strategic development of service activities within Medidee
• Participate in Medidee training programs and represent Medidee in congresses and fairs
We are looking for individuals with:
• a successful track record in the development or industrialization of Medical Devices
• a scientific or engineering background
• at least 2 years of experience in Regulatory Affairs and / or ISO13485 QMS implementation
• good communication and networking skills, ease to speak in front of an audience
• excellent command of English And, depending on the region, German, Swedish or Danish (all other language skills are an advantage)
• the maturity and strength to work independently and structure/prioritize the work required.
Working with us
We offer projects involving cutting-edge innovation in the MedTech industry that will require quick learning of technical and medical concepts to best guide our clients. Within our international team of engineers, scientific and clinical experts, you share experiences and complement your and your colleagues’ competences. Traveling is also part of the experience.
You have the chance to join a fantastic team of super competent people, all hungry for new challenges. Regardless of where we work, we are ONE team that interacts regularly, both online and in real life.
Please note: We are specifically looking for applicants out of the above-mentioned region and the surrounding area. If you want to apply out of other regions, please get in contact with the correct person based on our contact page.