Our client, a leading medical devices organization with headquarters for EMEA in Antwerp region, is hiring a Regulatory Affairs Manager. With rapid growth for several years and future expansion plans, you will have the opportunity to make a significant impact in your role, grow alongside the company, and contribute to shaping the future of the company as it continues to evolve.
Benefits:
– Products with good reputation on the market making you proud of the company you work for and your indirect positive involvement on the benefits the devices offer to patients
– Strong support from CEO and VP RA/QA to shape the department as business partner making your role more valuable and you can have a tangible impact on business decisions
Responsibilities:
– Lead and manage a team of regulatory affairs professionals, fostering their growth and performance
– Drive the regulatory strategy in alignment with business objectives, ensuring compliance with MDR and ISO 13485
– Prepare technical files for premarket submissions in EMEA, positioning the regulatory affairs function as a strategic business partner
Requirements:
– Minimum 5 years of RA experience in the medical devices industry
– Strong knowledge of MDR and ISO 13485
– Experience in premarket submissions in EMEA, with post-market experience being a plus
– Leadership or people management experience preferred
– Fluent in English, Dutch proficiency is advantageous
If this job appeals to you please apply here or send your CV to me, Annelies De Baere, on the NonStop Consulting website or on my Linkedin. If you are not available but you know someone that would be interested, please forward this to them and help the people in your network.
Do you have any disability or condition that could affect you in the application and interview process? Please feel free to share this information as part of your application, including any necessary adjustments you might need, so we can help make the process easier for you. We assure you this information will not have any negative effect on the interview process outcome.
About our client: We are NonStop, a leading provider of staffing solutions throughout Europe and now also in the US. We’re passionate about connecting talent with opportunity and work non-stop to support our clients in hiring the best talent for their teams. Feel free to pop over to our website, NonStop Consulting (nonstopconsulting), for more information, to browse all our roles, or to let us know how we can help you.
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