- 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.