IVD Risk Manager
Exscientia, Austria

Exscientia is an AI-driven pharmatech company committed to discovering, designing and developing the best possible drugs in the fastest and most effective manner. Exscientia developed the first-ever functional precision oncology platform to successfully guide treatment selection and improve patient outcomes in a prospective interventional clinical study, as well as to progress AI-designed small molecules into the clinical setting. Our pipeline demonstrates our ability to rapidly translate scientific concepts into precision-designed therapeutic candidates, with more than 25 projects underway. By designing better drugs, faster, we believe the best ideas of science can rapidly become the best medicines for patients

As the IVD Risk Manager you will have the opportunity to:

• Develop system, processes, and documentation templates for IVD risk management (risk assessment matrix, hazard identification, risk analysis, risk evaluation, risk control and benefit-risk analysis) in alignment with IVDR, ISO 14971:2019 and ISO/TR 24971 requirements
• Document and maintain product specific risk management file - risk management plan, risk traceability matrices, risk management report
• Provide expertise and content input into hazard analysis, design / use risk analysis and document results of the risk management activities
• Lead in the effective documentation of risk management throughout device development, to drive or participate in discussions and decisions related to product safety and user risks
• Work with engineers and scientists to assess design changes and change requests from systems perspective, identifying risks, driving design mitigations, and evaluating effectiveness of the risk control measures
• Coordinate between other workstreams /departments contributing to risk management (development, quality, regulatory affairs, engineering and usability), to ensure that risk controls are implemented, verified, and validated
• Train staff in product risk management principles within the organisation
• Support the IVD development team with the implementation, management and maintenance of a suitable quality management system for device development
• Collate and maintain device associated technical documentation (design history, device master record/technical file.conformity assessment ect.)

• Develop transferable processes and procedures to enable partner sites (labs, hospitals, CRO) to undertake risk management activity within their institution
• Lead on the implementation and management of quality management processes, with a focus on risk controls measures, for our precision medicine device development activities
• Develop training and onboarding material to ensure our teams can effectively contribute to device risk and quality management processes
• Ensure the efficient completion and maintenance of device associated documentation using digital tools within the quality management framework.

Requirements

• Bachelor’s degree in relevant field (BA, BSc), or higher
• Structured training or experience in:
  • The EU MDR, IVDR or IVDD
  • Risk Management (ISO 14971) amp; ISO/TR 24971
  • Quality Management (ISO 13485)

• At least 2 year’s experience working with applicable industry standards and regulations, namely IVDR, ISO 14971, ISO/TR 24971
• Working experience with a state of the art risk assessment method (e.g. FMEA, PHA, HAZOP, FTA etc.) applied in a medical device setting
• Working experience with medical device quality management systems (21 CFR 820 and/or ISO 13485)
• Experience in linking and aligning product risk management to all other elements of medical device quality management system (design controls, document control, CAPA, verification amp; validation processes)
• Experience in the collation and management of medical device associated technical files (DHF, DMR, ect.)

Benefits

Exscientia provides a competitive compensation package in accordance with the Austrian collective bargaining agreement, starting from a minimum of 45.000,- gross per year. We will negotiate an attractive package and overpayment based on your background and previous work experience.

Job Rewards and Benefits