PlusOne

QA & RA Director - Medtech - Brussels

Company

Our client is a Belgian company that distributes medical devices designed by reliable and internationally well-known suppliers. Over the years, this small business has become the preferred partner of hospitals and health professionals in providing bespoke solutions through its committed sales force.

The company (part of a European group) is active internationally in four 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: further subdivided into the Interventional Specialties, Wound care, Vital Care, Daycare and Daycare NL departments
  • Surgery: further subdivided into Cardio-vascular and Spine departments, and general surgery focusing on the needs of the operating room

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

Today the company distributes 150 reliable brands of medical devices, on the Benelux market and offers integrated solutions for different groups of customers groups in Belgium and Luxemburg. The turnover grew for the tenth consecutive year.

Role

You role & Responsibilities

  • 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 group

Additional activities and beside projects

  • In addition to daily routine QA-RA work and of specific solving of problems:
  • AFMPS-FAGG medical devices/implants inspections (3 - 4x/year)
  • Quality agreements with manufacturers and suppliers, distribution agreement contract review
  • Raising to higher standard TSC-be QMS for recertification ISO 9001 & ISO 13485
  • Setting up and implementing a QMS documentation software
  • Support to INAMI-RIZIV reimbursement dossiers
  • Legislation analysis and implementation of Sunshine Act / Transparency.be requirements
  • Regulatory watch
  • Insuring implementation and follow-up of all new MDR requirements for distributors and importers (CE certificates, UDI’s…)
  • Biocides / SPF-FOD : legislation understanding and implementation and follow-up of reporting to Authorities of the quantities of product distributed
  • Maintain contacts between all support departments and commercial divisions in the company

Profile

  • (Industrial) Pharmacist (Master, PhD) or Master in Sciences
  • Dutch, French and English: Fluent spoken and written
  • 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

Offer

  • A welfare work environment in a very high level qualified small team
  • An attractive salary with extralegal benefits
  • Permanent contract, Full time job (39 hours/week)
  • Location: Brussels (very close to the Brussels South Train station)
  • Start date: ASAP

Publication date

14.09.2021

Contact person

Gaëlle Minet

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