Senior Regulatory Engineer Budapest

Senior Regulatory Engineer
Budapest
Budapest, HU

Our goal is to improve the lives of thousands of patients through our transplantation diagnostics tests. This is what inspires us.

The Senior Regulatory Engineer’s key focus is on IVD medical device quality assurance. The incumbent will be reporting to the Chief Technical Officer and be working closely with other departments as well. , RESPONSIBILITIES

• General Regulatory Management
  • Managing IVD medical device feasibility based on regulation of targeted markets
  • Partnering with key stakeholders for the creation of the regulatory strategy and roadmap
  • Establishing and maintaining of the regulatory profile for IVD medical devices
  • Ensuring that regulatory requirements for IVD medical devices are specified and kept up to date
  • Establishing and maintaining the technical documentation
  • Managing regulatory approval process of IVD medical devices

• Product Regulatory Expert
  • Acting as Product Regulatory Expert for assigned product families, including product regulatory planning
  • Acting as Person Responsible for Regulatory Compliance (PRRC) according to Article 15 of Regulation 2017/746 (IVD-R), including but not limited to:
  • Establishing and maintaining of the Technical File/Documentation
  • Establishing and maintaining of the Declaration of Conformity (DoC)
  • Ensuring that Post-Market Surveillance (PMS) obligations are complied
  • Ensuring the issuing of the PEO statement for performance studies
  • Managing and monitoring of Performance Evaluation (incl PMPF) activities
• Partnering with Quality Management and Research and Development
  • Monitoring of standards and guidance documents related to IVD medical device regulatory profiles
  • Partnering to identify gaps within and to improve processes and procedures
  • Supervising the documentation of processes related to regulatory compliance
  • Monitoring product and process performance and reporting to key stakeholders
  • Other duties as assigned

• 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
• Self-motivated, works well with minimal supervision
• Strong analytical skill and knowledge of statistical methods
• Sound problem-solving skills
• Advanced English

• Experience in the field of molecular biology, genetics, immunology
• Experience with clinical studies

• Performance-related annual bonus
• Cafeteria with optional elements (Gross 45. 000. HUF per month)
• Laptop
• Free coffee and beverages
• Free parking
• Pleasant office and family atmosphere
• Challenging and innovative work
• We care for your work-life balance
• Company events