Quality/Regulatory Specialist (M/F/X)

As Quality & Regulatory Specialist, you maintain, implement and improve our quality system according to ISO 13485 norm.
You think in terms of processes and can write out processes, policies and work instructions.

Are you the 'RAQA' Team member we are looking for ?

Belgique

For Duomed Belgium, based in Aartselaar, we are looking for a Quality/Regulatory Officer (M/V)

Duties/Responsibilities:

  •     Maintain, implement and improve the Quality Management System (QMS) according to ISO 13485
  •     Manage the implementation of a single Belux QMS according to ISO 13485
  •     Be process oriented, and able to issue processes, policies and work instructions.
  •     Monitor the QMS : KPI (Quality objectives and other indicators), complaints, supplier evaluation, CAPA, audits (internal, and if needed, external)) …
  •     Question the status quo and manage improvement actions with stakeholders
  •     Raise awareness and train colleagues on QA/RA conscious mindset
  •     Assure compliance with applicable legislation related to organization’s activities (MDR, IVDR, Biocides, …)
  •     Manage the quality mailboxes and ensure appropriate follow-up
  •     Implement and manage the product library and the QMS processes
  •     Assist in translating the business strategy into operational processes, taking into account all regulations and stakeholders (e.g. new distribution, update ISO standards, etc.)
  •     Manage and implement updates of regulation updates
  •     Optimize all processes in collaboration with the other departments

You will be part of and supported by the Quality/Regulatory Team.

Skills:

  •     Be a strong assertive communicator with diplomacy
  •     Have a pro-active mindset
  •     Take initiative
  •     Be pragmatic and efficient
  •     Be customer-oriented, independent, analytical, stress-resistant, flexible, organized
  •     Teamplayer
  •     Take Ownership for managing tasks
  •     Be motivated
  •     Experience with ISO 13485, ERP, …
  •     Good knowledge of Microsoft Office (Word, Excel, Outlook, etc.)
  •     Knowledge of medical device legislation (MDR) is an added advantage
  •     Trilingual Dutch / French / English (spoken and written)


Our offer:

  •     Part of a young and dynamic RAQA team
  •     Training as required (product, ERP, ..) : both internal and external
  •     A job with a lot of variety of tasks and interaction within the BeLux structure as well as with the other Duomed affiliates
  •     Possibility to learn and develop your skills
  •     Very open atmosphere with room for initiative
  •     A challenging environment where wellbeing and results go hand in hand.
  •     We offer you an open-ended contract (after a possible interim period), supplemented with fringe benefits such as meal vouchers, AG group insurance (pension, death & guaranteed income), DKV hospitalization insurance, purchasing power premium and eco-cheques within Joint Committee 200.
  •     Room for initiative, in a company with an excellent reputation in the medical world.