Regulatory Affairs and Quality Assurance Manager

Brussel Vast dienstverband €83,000 - €94,067

Toegevoegd 13/09/2021

  • Regulatory Affairs & Quality Assurance Manager
  • Medical Devices - region Brussels

Over onze klant

Our client is a company which distributes medical devices designed by reliable and internationally well-known suppliers.

The company is active in 4 main fields of activities:

  • Infection Prevention: the best solution for everything related to medical hygiene.
  • Sterilization Equipment: supply you with solution and service for your central sterilization department.
  • Interventional Care: specialized products in wound care, vascular access, temperature management and anesthesia.
  • Surgery: further subdivided into Cardio-vascular and Spine departments.

Each division offers a complete package of disposables, capital equipment and services to meet its customers' changing needs.

Our client distributes 120 reliable brands of medical devices -on the Belgian or Benelux market- and offers integrated solutions for different groups of customers groups in Belgium and Luxemburg.


The QA-RA manager will take the lead of the QA-RA department covering the following activities:

  • Administrative follow-up/supervision of customer complaints about product quality issues.
  • Layout and drafting of various QA-RA documents including organizational procedures, quality manual, internal audit reports
  • Conducting internal and external audits: planning of audits, routine interview, reports writing
  • Supervision through the commercial Divisions of the writing and inventory of ISO Work Instructions, supplier evaluations
  • Supervision and verification of the environmental storage conditions of the products stored in the warehouse
  • Insuring fulfilment of all Good Distribution Practices requirements with regard to the distribution of medicinal products and medical devices
  • Staff assistance with mandatory ISO 9001 & 13485 standards pre-audit documentary updates (quality objectives matrix and KPI's, document management database, process sheets, annual listing of staff trainings, frequency statistics of product complaints, staff competence, list of approved suppliers
  • Check through the commercial Divisions for exhaustive AFMPS-FAGG authorization/notification of current manufacturers (and getting/recording/archiving all necessary CE certificates and declaration of conformity, including expiry inventory)
  • Compliance management (code of ethics and business compliance implementation and follow-up)
  • Harmonizing the Quality within the company and providing of training to (new) staff regarding mandatory QA-RA topics
  • Consistency of quality and regulatory affairs practices within the various subsidiaries of the TSC group


  • (Industrial) Pharmacist (Master, PhD) or Master in Sciences
  • English: Fluent spoken and written
  • Dutch and French: working proficiency
  • Active knowledge of GDP (Good Distribution Practices), ISO 9001 and ISO 13485 standards and qualified for conducting internal audits
  • Registered as Person Responsible for Information - FAMHP
  • 3 to 15 years of experience in Quality Assurance Management and/or in Regulatory Affairs in the medical device or pharmaceutical sector
  • Excellent command of Word, Excel and PowerPoint
  • High organizational skills, good interpersonal skills, flexibility in tasks and schedules
  • Sense of responsibility, enthusiasm, diplomacy and determination to learn are a must


- A very challenging job in a stimulating department with a high degree of autonomy, in a stable company with a very good reputation.

- A competitive salary.

Michèle Verloigne

Vacature samenvatting

Sub Sector
Contract Type
Consultant naam
Michèle Verloigne
Vacature referentie

PageGroup is een werkgever die gelijke kansen biedt en zich inzet voor diversiteit, zowel als werkgever als werving- en selectiebureau. Elke beslissing die we nemen bij het aannemen van mensen bij kandidaten die we in nieuwe rollen plaatsen, is uitsluitend gebaseerd op de kennis, ervaring en vaardigheden van de kandidaten.