Company details Keyrus Biopharma, member of the international group Keyrus, is a European full-service Contract research organization (CRO) providing biopharmaceutical, nutritional, cosmetic, animal health and medical device industries with a broad range of clinical research services from early- to late-stage clinical development, including regulatory affairs, project management, clinical monitoring, scientific and medical support, site management, biostatistics, data management, product safety, quality assurance and medical & scientific communication. Our consulting operations department is looking for a Post Market vigilance Consultant (m/f) for one of our clients, a company which is specialized in Medical devices, located in the south of Brussels (/-30km): Duration : 2 months assignment Status : Freelance or Keyrus permanent member of staff - Full-time – Work on site - No home based work Start date : 1st march Function As post Market Vigilance Consultant, you will provide expertise and consultancy to the Regulatory Affairs department (25 people) and help the 2 post market vigilance associates to define a strategy for MDR (medical device reporting) and recalls. Establish a good diagnostic (audit) Write SOP’s (standards of procedures) Share his/her experience with the team Create recall escalating processes. Profile 5 to 10 years working experience in a Medical device company, in a Regulatory Affairs and/or Pharmacovigilance department, dealing with MDR (medical device reporting) and recalls Experience in writing SOP’s Experience in medical device vigilance Excellent communication and training skills Fluent in English (can be English native speaker) Keywords : regulatory affairs, post market vigilance consultant, post-market, post-market surveillance, vigilance, medical device, consulting, vigilance consultant, regulation, regulatory, quality, SOP, pharmacovigilance, medical device reporting, MDR, permanent contract, freelance contrac, medical device vigilance, Iso, risk management, risk assessment Offer A two months challenging assignment in a well-known medical devices company An opportunity where you can provide expertise.