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Senior Quality Assurance & Regulatory Affairs Manager

Responsibilities and job description

The QA-RA manager will take the lead of the QA-RA Dpt. 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

 

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

Your Profile

  • (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
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