Senior Quality and Regulatory Engineer, (HU)

Senior Quality and Regulatory Engineer

This position’s key focus is on IVD medical device quality assurance. She/he reports to RAQS manager and work closely with Chief Technology Officer’s team as well.

 

Your Responsibilities In This Position Are To

Regulatory management

  • Manage IVD medical device feasibility based on regulation of targeted markets and support RAQS manager in creating regulatory strategy/roadmap
  • Create and maintain regulatory profile for IVD medical devices
  • Ensure that regulatory requirements for IVD medical devices are specified and kept up to date according to the concerning technical procedure
  • Review technical document for completeness
  • Manage regulatory approval process of IVD medical devices

Quality System management

  • Monitor applicable standards and guidance documents related to IVD medical device regulatory profile, identify gaps and introduce new/modified quality processes/procedures for compliance
  • Ensure that processes related to regulatory compliance are documented completely
  • Collect and analyse data on product and process performance and report to RAQS manager and CTO with suggestion for improvement
  • Drive investigation and problem solving of potential major/critical complaints and CAPAs; coordinate the work of Field Support and R&D in this regard
  • Build up regulatory awareness and knowledge in technical teams
  • Lead quality initiatives, projects
  • Support execution of annual audit plan by performing internal and supplier audits
  • Participate in risk assessment

Required Skills and qualifications

  • MSc in Life science
  • Minimum 3 years quality and regulatory experience in medical device field (or similar: pharma)
  • Experience with ISO 13485, CE marking, FDA approval
  • Experience in the field of molecular biology, genetics, immunology (advantage)
  • Experience with clinical studies (advantage)
  • Able to work independently
  • Strong analytical skill and knowledge of statistical methods
  • Above-average problem-solving skill
  • Advanced English

What We Offer

  • Challenging and innovative work
  • Modern office and environment
  • Welcoming, easy-going team spirit
  • Home office possibility
  • We care for your work/life balance
  • Competitive salary
  • Cafeteria

 

Start Date: ASAP
Type of Position: Full time
Base Location: H-1117 Budapest, Fehérvári út 50-52

Our company culture builds connections, careers and employees grow by creating a workplace that values flexibility, autonomy, and transparency.

Sounds just like you?

Pease send us your CV in English with your Gross salary expectations and possible start date.

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