REGULATORY PROJECT MANAGER

BeerseIPharmaceutical Sector

Job description

For one of our pharmaceutical clients in Beerse, we are currently looking for a REGULATORY PROJECT MANAGER. 

You will support for the Regulatory Diagnostics team for registration of Software as Medical Device and Companion Diagnostics in the EMEA region.

The assignment includes following activities: 

  • Prepare or review regulatory strategies and plans for Medical Devices and In Vitro diagnostics
  • Perform regulatory assessments for product qualification as medical device
  • Coordinate product regulatory GAP assessments against MDR 2017/745 and relevant harmonized standards
  • Create or review Technical Files and design dossiers for submission in EMEA. This might involve interacting with external development parties.
  • Coordinate responses to requests from notified bodies and regulatory authorities in order to expedite approval of regulatory submissions
  • Evaluate regulatory impact of product changes
Profile

As regulatory project manager:

  • You have a Bachelor's or Master's degree in biochemistry, microbiology, pharmacy or life-science or health-related discipline
  • You have minimum 10 years' experience with regulatory strategies and EU conformity assessments for molecular In Vitro Diagnostics (IVD Dir 98/79/EC) and Medical Devices (Dir 93/42/EEC)
  • You possess knowledge about design controls, software development process, computer system validation and cybersecurity
  • You are familiar with development of PCR tests or next gen sequencing, validation and performance characteristics of such test, clinical validation protocols and reports
  • You are proficient in Dutch and English; mastering French is an asset
  • You are a collaborative team player with a dynamic personality
  • You have excellent verbal and written communication skills
  • You are a detail-oriented regulatory leader
Organisation and department description

Select Projects is part of the Select group, a collection of HR companies that put people first because Quality is Performance by Genuine People. Select Projects provides technical support to clients on a project basis. Our 220 employees in Belgium and the Netherlands support companies with their projects in various domains: Life Sciences, (petro) chemical, Construction and Rail. From our offices in Antwerp and Rotterdam we optimally support our experienced specialists so that they can deliver high quality to our customers at all times.

Offer

You get an attractive salary package with interesting fringe benefits. A company car, meal vouchers, group insurance and mobile phone subscription are possible. We ensure that you end up in a pleasant working environment with nice colleagues and opportunities to develop and further develop. Together with you, we map out a training course tailored to your future plans and needs.

Any questions?
Marlies Collart Consultant Life Sciences Select Projects +32 3 203 50 80
REGULATORY PROJECT MANAGER Vacancy information
67259
R and D - Science and Scientific Research
Project Sourcing
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