To ensure the safety of medical devices developed at Affluent Medical by applying the risk management process throughout the entire product life cycle.
JOB DESCRIPTION
RELATIONSHIPS AND/ OR FUNCTIONAL
Exchanging information with the project teams (Kalios, Artus and Epygon) Quality, Regulatory Affairs, Clinical Affairs, R&D, Industrialization and Production.
Maintain a proper communication with the Human Factors Engineer regarding the collection of usability datas.
Exchanging informations with experts for specific needs.
Exchanging information with physicians and DM distributors as part of risk assessments.
Maintain a proper communication with the Human Factors Engineer regarding the collection of usability datas.
Exchanging informations with experts for specific needs.
Exchanging information with physicians and DM distributors as part of risk assessments.
MAIN MISSIONS & ACTIVITIES
- To prepare and keep updated the risk analysis for medical devices in compliance with relevant standards and guidelines
- To create and/or update of the Risk Management File
- To coordinate risk and usability files.
- To assess the risk for complaints, non-conformities or others possible improvements from external (physicians or distributors) and/or internal (R&D, Quality, etc.)
- To participate in regulatory inspection and notified body audits as risk management subject matter
- To collect inputs and datas form HFE to compile the usability risk management file.
RESPONSIBILITIES
To monitor documentation and regulations as part of the continuous improvement of product safety.
To plan and execute of risk management activities throughout the product development cycle to ensure product safety.
To plan and execute of risk management activities throughout the product development cycle to ensure product safety.
AUTONOMY
The Product Risk Manager draws on the business expertise of the project teams. He/she reports to his/her manager on a weekly basis and according to defined priorities.
SKILLS REQUIRED
- Theoretical knowledge
Advanced scientific or technical education in Biomedical, Electrical, Mechanical, Software Engineering, or other technical or science discipline.
- Practical knowledge
Experience of minimum 3 years risk management for medical devices or pharmaceuticals.
Advanced knowledge of medical device regulations (MDR 745/2017, MDSAP etc.).
Advanced knowledge of applicable quality management and of risk management standards (e. g. ISO13485, ISO14971, ICH Q10, EU GMP, FDA 21 CDR §820.250).
Knowledge of FMEA methodology and of functional and constructive safety concepts.
English (written, read and spoken)
CANDIDATE
To apply for this vacancy, please send your application to jobopportunities@affluentmedical.com