Product Safety Manager
Overview of Position
The Product Safety Manager is responsible for establishing and implementing processes for pre-market risk management activities for Enterprise Imaging medical device products, and to collaborate with the QARA Post-Market Compliance team to evaluate complaints that have been identified as a potential safety concern, in accordance with the requirements of applicable medical device regulations.
What will be my duties and responsibilities in this job?
Establish and maintain the product risk management process to remain compliant with relevant regulations for jurisdictions where Enterprise Imaging solutions are marketed.
Provide coaching and guidance to the product management team in product risk management activities and ensure relevant pre-market risk management output (e.g. PHA/PRA) are generated as part of the product development activities.
Facilitate the clinical evaluation activities with clinical SMEs for the release.
Consolidate and finalize pre-market risk management output as part of the DHF or Technical File for the product release.
Consolidate and finalize post-market surveillance output for Enterprise Imaging products.
Serve as the point of contact for QARA Regulatory team for medical device clearance submission evaluation.
Serve as the point of contact for QARA Post-Market Compliance team to evaluate potential safety incidents involving Enterprise Imaging products.
Provides input to the identification and mitigation of potential hazards for Enteprise Imaging medical device products during product design and development, as required.
Collaborates with appropriate stakeholders, as required, to complete evaluations of potential safety incidents involving Enterprise Imaging medical devices.
What are the requirements needed for this position?
5+ years' experience in high tech and application software industry, with minimum 3 to 5 years in a project management or cross-functional coordination role. Knowledge and working experience in project management, system integration, problem analysis and troubleshooting.
Requires knowledge of Enterprise Imaging products.
What other skills/experience would be helpful to have?
Requires achieving challenging deadlines in a fast-paced environment.
Requires familiarity of product development practices.
Requires knowledge of applicable regulatory requirements.
Knowledge of medical device regulations and standards applicable to Enterprise Imaging product/solution, including:
ISO 13485:2016 Medical Device Quality System Requirements,
ISO 14971:2007 / ISO 14971:2019 Medical Device Risk Management
U.S. FDA Quality System Regulation (21 CFR 820)
Canadian Medical Devices Regulations (SOR/98-282)
EU Medical Device Regulation (MDR) 2017/745
What are the working conditions and physical requirements of this job?
How much should I expect to travel?
Must be able to travel up to 25%.
Employees in roles that require travel will need to be able to qualify for a company credit card or be able to use their own personal credit card for travel expenses and submit for reimbursement.
Join our team today where we are creating a better coordinated, increasingly collaborative, and more efficient healthcare system!
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