Post Market Vigilance Consultant

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

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.

• 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

• A two months challenging assignment in a well-known medical devices company
• An opportunity where you can provide expertise.