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
- NHS DCB0129
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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