This role can be based in any of these EU countries: Spain, Poland, Bulgaria, France, Italy, Germany
The Risk Manager is responsible to maintain risk management activities for legacy devices and to support new product development activities.
The Risk Management Engineer reports into the R&D Director to contribute directly to meeting regulatory submission, launch timelines of medical devices and aesthetic products as well as regular review activities.
Main Responsibilities
* Lead and coordinate all risk management activities according to ISO 14971, ISO 13485, MDR and annex XVI.
* Plan, prepare and perform risk management for medical devices and aesthetic products according to project phases following all relevant internal procedures, processes, and external requirements for development products.
* Represent Risk Management on assigned development projects.
* Establish risk acceptance criteria for individual residual risks and the overall residual risk for specific devices in development and for legacy devices
* Maintain a close link to the Human Factors/ Usability Engineering process to meet the needs and ensure the safety of all users and patients.
* Support creation of device design specifications to ensure that risk control measures are appropriate.
* Monitor that risk controlmeasures have been implemented, verified,and validated.
* Maintain knowledge of current Company policies, standards and guidelines as well as industrypractices, regulatory requirements, and other relevant information.
* Ensure harmonized approaches to risk management across projects. Communicate with Research and Development team members on other projects to share lessons learned and ensure use of common tools and ideas within the team.
* Ensure that the risk management process incorporates all relevant data from the Design Authorities e.g., Design FMEAs, Security Risk Analysis, Use-related risk analysis, formative human factors evaluations and human factors validation studies.
* Ensure that risk management reports are prepared in a timely manner and in accordance with ISO 14971 and applicable Company SOPs and guidelines and are adequate for inspection by notified bodies and other relevant authorities.
* Present project-specific risk management activities at regulatory body inspections and internal audits.
* Work cross-functionally with other global functions: e.g., Global Marketing, Global Regulatory Affairs, Clinical Affairs and Manufacturing.
* Support a good link between risk management during development and risk management for marketed products.
* Ensure that all hazards associated with a medical deviceand aesthetic products are identified, the associated risks are estimated and evaluated and that these risks are controlled; monitors that these risk controls are implemented, verifiedand validated.
* Assures that Company quality and compliance standards and applicable government regulations are met by means of independent risk management for medical devices under development.
* Performs risk management in medical device and aesthetic projects and assists medical devicesites in ensuringthat risk management is performed in sufficient detailand in a timely manner for new device introductions and regulatory agency inspections.
* Has overall responsibility that medical devices and aesthetic products are designed to be safe, effective and in compliance with the applicable regulations worldwide.
Required Experience & Qualifications
* Minimum of 2 years of experience in regulated medical device industry
* Knowledge of usability engineering or human factors engineering for medical devices
* Knowledge in usage of risk assessment methods
* Masters Degree of Engineering degree in the following fields or equivalent (Materials, Biomaterials, Chemistry, Biochemistry, Biology)
* English: Fluent
Plus to have:
Experience in the manufacture of Medical Devices
Good knowledgeof medical standards, e.g.:
* ISO14971:2019
* ISO13485:2016
* MDR
* Annex XVI (MDR)