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.