Technomed is looking for a new talent! Regulatory Affairs Associate Location: Maastricht-Airport (NL) Who is Technomed?
We believe that technology can have a major impact on patients' lives. That is why we are proud to be on your nerves! Our products transform a bio-electrical signal from patient to medical equipment to measure the nervous system of brain and muscle activities.
Technomed Engineering BV, together with the British company Magstim and Magstim EGI, is part of the international Welcony group that develops and produces medical equipment and accessories. The international group has four brands: Neurosign, Technomed, Magstim and Magstim EGI.This role is mainly for the brands Neurosign and Technomed. This business unit has its headquarters in Maastricht-Airport (the Netherlands), production in Indonesia and a sales and logistics operation in the US.
You can count on a multidisciplinary team, a pleasant, collegial and challenging working atmosphere, in which independence and self-initiative are appreciated. We offer you a structural full-time job of 40 hours at our location in Maastricht Airport. You are part of a self-organising team in which you can make a life changing difference!Who are we looking for?
Due to continuous growth, Technomed is looking for additional staff members to join its quality assurance and regulatory affairs team. As Regulatory Affairs Associate and member of the quality assurance and regulatory affairs team you will be playing a key role in product safety and regulatory compliance by providing administrative and coordination support for several Quality Assurance and Regulatory Affairs activities. You are also co-responsible for the maintenance and renewal of existing registration and licenses, worldwide.What’s the job?
Who are you?
- Being main contact to answer various requests from customers and / or authorities worldwide for the renewal and / or maintenance of existing registrations. This involves:
- the collection and/or preparation of the requested technical and administrative documentation;
- ensuring notarization, legalization and apostille process for regulatory documentation;
- dealing with multiple requests in parallel.
- Ensuring a thorough understanding of the Technomed products and their regulatory documentation.
- Being responsible for managing multiple tasks daily, assisting the members of the quality assurance and regulatory affairs team to support compliance with global regulatory requirements.
- Creating and/or maintaining various department and regulatory data basis including the collection of the required data (UDI, Eudamed, FDA listings, …)
- Ensure a timely collection and review of updated technical documentation required to maintain product compliance from different suppliers.
- Assisting the Regulatory team in the preparation of any new submissions, tracking dates of substitution, requests and answers.
- Working across full suite of Microsoft office software programs, Adobe, and multiple internal software programs/databases.
What is our Technomed DNA?
- Bachelor / Master degree in physical/biological sciences or engineering or equivalent
- Minimum 2 years’ experience in Regulatory Affairs and/or Quality Assurance in a medical device company.
- Demonstrated ability to communicate effectively both verbally and in writing in English and Dutch
- Advanced skills in Microsoft Excel, Word and Powerpoint.
- Proven good organizational skills.
Technomed has an open, informal culture with an enthusiastic team and short lines of communication. Responsibility, innovation and creativity form the basis of our growing and learning organization. We take innitiative and ownership. We deliver better patient outcome and for us quality is key! How to apply
Interested in this position at Technomed Europe? Please send your CV and motivation letter by submitting your application by using our Online Application Form
. For questions and more information about the Regulatory Affairs Associate vacancy, please contact Monique Berwaer (Manager QA/RA) on phone number 043 408 6868
. Website: Go to website
Trefwoorden: Regulatory Affairs Specialist, Regulatory Affairs Manager, Regulatory Affairs, Regulatory Affairs Officer, Biomedical Engineering, Validation Engineer, Verification Officer, Quality Engineer, ISO 13485, Medical Devices Directive (MDD), Medical Devices Regulation (MDR), FDA, Regulations, RA, RA medewerker, Clinical Research, Biomedical, Medical Devices, Government
Acquisitie n.a.v. deze advertentie wordt niet op prijs gesteld.
Meer informatie >>