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İlan Detay
Risk Management Post Market Surveillance Specialist
İstanbul Anadolu, İstanbul Avrupa
Occlutech Tıbbi Ürünler - Risk Management Post Market Surveillance Specialist
Job Definition
- 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.
- 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.
- 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.
- Collect and prepare data related to Post Market Surveillance and Risk Management.
- Act as an interface between the Product Surveillance team and Regulatory, Quality, Clinical, R&D and Marketing team to gather appropriately PMS data.
- Generate, maintain, and complete the Post Market documentation (Periodic safety update report, PMS report & Plan) subject to review by regulatory agencies.
- Support Risk Management and Product Surveillance process activities and training
- Providing risk management process related inputs for the risk management process performance to management review reports.
- Supporting providing risk management inputs for the ECR, CER and complaints
- Responsible for risk management activities (primary focus mVSD, PLD, PmVSD, PIVSD when necessary other projects) (See Att.02_Risk Management Tasks Distribution)
- Preparation of the Risk Management Statements and handling of the continued risk management process (CRisk) due to relevant inputs from PMS data.
- Primary contact for risk assessment of the biological evaluations
Qualifications
- Bachelor’s degree in life science or engineering (or related field)
- Significant knowledge of European Medical Device Regulation and ISO 14971
- 1 to 2 years in risk management and/or post-market surveillance of medical devices
- Fluent English
- Ability to work autonomously and accurate in every detail.
- Strong organizational, planning, and analytical skills, results oriented.
- Excellent communication and interpersonal skills, ability to work in international environment with cross-functional team
- Must be self-directed and able to prioritize tasks to meet the needs of multiple business units.
- Strong analytical and problem-solving skills
- Ability to collaborate with cross functional teams.
- Excellent knowledge of MS Office