You will be responsible for the following activities:
- Driving Quality & Regulatory compliance while aligning with the overall organization to meet business needs & objectives.
- Monitoring our product performance in the field (Post-market Surveillance, PMS), performance of manufacturing and start and coordinate improvement projects when needed.
- Organising, preparing and maintaining Technical files – including organising and preparing of necessary country registrations and renewals in e.g. EU, USA, Canada etc.
- Monitoring, reporting and implementing regulatory developments.
- Assuring Quality & Regulatory compliance in product development, process development and change projects.
- Responsible for CAPA, validations, inspections, document control, regulatory affairs and problem resolution
- Review & approve product documentation (including labelling) and product marketing literature for regulatory compliance, PMS, proofing the claims we make, marketing purposes etc.
- Preparing and monitoring of the quality objectives and reporting of the management review.
- With a MSc degree or higher in science, (biomedical) engineering, (technical) medicine or a related field with 3+ years of relevant experience in medical device QA&RA
- With knowledge of medical devices regulatory frameworks including MDD/MDR, FDA 21 CFR 820 and standards like the ISO13485:2016 as well as other applicable global regulatory frameworks and standards.
- Who is familiar with Medical Device (Software) product development and technical files, with knowledge of medical device standards e.g. IEC60601 or IEC62304.
- With excellent interpersonal skills and communication skills, written and oral, in English. Dutch is a pre.
- Who is flexible when the ‘dynamics’ of the job ask for it.
- Last but not least; we are looking for somebody with whom it is fun to work. Although we are very serious about our business, we find it important that we enjoy it as well!
Many possibilities regarding personal development through our wide internal and external course offer. We welcome your own initiative, and give you space to do so. Accordingly, this also includes a competitive salary and flexible terms of employment.
Thanks to our engaged colleagues, communication lines are short and the atmosphere is open and informal. There are many friendly encounters, both in- and outside of work. We have an active staff association that organizes several activities throughout the year.
Bedrijfsprofiel DEMCON advanced mechatronics
Finapres Medical Systems B.V. develops and distributes medical devices for noninvasive continuous hemodynamic monitoring. These devices are the result of over 30 years of research and user-experiences in this area of expertise. Finapres is acknowledged as the gold standard of beat-to-beat non-invasive blood pressure measurements.
Our solutions are a combination of hardware and software applications. From the office in Enschede, Finapres maintains worldwide distribution and sales of its proprietary products through a distribution network and direct sales. Finapres (www.finapres.com) is an associated company of the Demcon Holding (www.demcon.com). Demcon is a supplier of high-end technology for medical devices.
As Finapres is part of the Demcon Group you can rely on the support and expertise of the QA/RA professionals within Demcon for larger projects.
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