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Occlutech Tıbbi Ürünler

Risk Management Post Market Surveillance Specialist

İstanbul Anadolu, İstanbul Avrupa

Occlutech Tıbbi Ürünler - Risk Management Post Market Surveillance Specialist

Job Definition

  1. Support Risk Management Team & Regulatory Affair department in Post Market Surveillance by reviewing, evaluating, and performing Risk management and Post Market activities on our medical devices by following European Regulation (EU-MDR), FDA 21 CFR part 820-803, ISO 14971, ISO 13485.
  2. Close collaboration with other departments and change management teams to assess the user risk related to Occlutech Products and create/update risk management files accordingly.
  3. Generate and complete the Risk Management documents (Risk Management Plan, Device Risk Assessment, Benefit-Risk Analysis, Risk Management Report) and keep Risk Management Files updated with PMS data.
  4. Collect and prepare data related to Post Market Surveillance and Risk Management.
  5. Act as an interface between the Product Surveillance team and Regulatory, Quality, Clinical, R&D and Marketing team to gather appropriately PMS data.
  6. Generate, maintain, and complete the Post Market documentation (Periodic safety update report, PMS report & Plan) subject to review by regulatory agencies.
  7. Support Risk Management and Product Surveillance process activities and training
  8. Providing risk management process related inputs for the risk management process performance to management review reports.
  9. Supporting providing risk management inputs for the ECR, CER and complaints
  10. Responsible for risk management activities (primary focus mVSD, PLD, PmVSD, PIVSD when necessary other projects) (See Att.02_Risk Management Tasks Distribution)
  11. Preparation of the Risk Management Statements and handling of the continued risk management process (CRisk) due to relevant inputs from PMS data.
  12. Primary contact for risk assessment of the biological evaluations

Qualifications

  1. Bachelor’s degree in life science or engineering (or related field)
  2. Significant knowledge of European Medical Device Regulation and ISO 14971
  3. 1 to 2 years in risk management and/or post-market surveillance of medical devices
  4. Fluent English
  5. Ability to work autonomously and accurate in every detail.
  6. Strong organizational, planning, and analytical skills, results oriented.
  7. Excellent communication and interpersonal skills, ability to work in international environment with cross-functional team
  8. Must be self-directed and able to prioritize tasks to meet the needs of multiple business units.
  9. Strong analytical and problem-solving skills
  10. Ability to collaborate with cross functional teams.
  11. Excellent knowledge of MS Office