QARA Consultant

Panda International

  • Maastricht, Limburg
  • Vast
  • Voltijds
  • 1 dag geleden
We are seeking a Quality & Regulatory Affairs (QRA) Specialist on a six-month contract to provide immediate support in post-market surveillance and regulatory reporting activities.This role focusses on delivering quick impact by supporting core complaint handling and vigilance processes.Key Areas of Responsibility:
  • Assures post-market regulatory requirements are met (e.g. required reports, supplemental submissions and other post-marketing commitments).
  • Reviews complaints and assesses them for regulatory reporting, within defined timelines.
  • Reviews and approves complaint investigations.
  • Handle all necessary complaint handling process activities.
  • Submit initial and follow-up reports to device related Agencies as needed, within defined timelines.
  • Works with quality investigators, local teams and customers on gathering information for reportability decisions.
  • Supports service review and complaint intake activities, if needed.
Education / Work Experience:
  • BS in Engineering, Science, or related degree; or MS in Regulatory Science.
  • Some relevant experience preferred.
Knowledge / Competencies:
  • Under supervision, performs work that is varied and involves limited responsibility.
  • Clearly conveys information to peers, supervisors, and other stakeholders.
  • Holds a general awareness of the business, products, and customers.
  • Knowledge of defibrillator products preferred.
  • Knowledge of applicable and international regulations and standards preferred, specifically:

Panda International