Risk Management Specialist Medical Devices F - Mx H/F - Nemera Lyon 7e - 69
- Bac +5
- Industrie Pharmaceutique • Biotechn. • Chimie
- Exp. + 7 ans
Risk Management Specialist F/M/X
(CDI)
Nemera is seeking a new Risk Management Specialist to join our R&D and Quality Teams, based in Lyon.
The Risk Management Specialist acts as a key enabler in the organization, harmonizing and standardizing risk management processes across Business Units. This role supports Quality, Design and manufacturing by providing standard tools, training, and guidance to ensure compliance with ISO 14971 and company standards. The Specialist fosters a culture of risk management excellence and drives continuous improvement initiatives.
This positions reports directly to the Quality Director.
Key Responsibilities
Risk Management System Harmonization :
- Develop, update and implement standardized risk management processes across all BUs.
- Create a Risk Management dictionary across all Bus aligned with existing
- Collaborate with Quality Managers to align risk management practices with corporate standards.
- Support the creation and maintenance of consistent Risk Management Files for all products.
Support and Enablement :
- Act as a resource for Quality, Design and BUs, providing guidance on risk assessments, FMEAs, and compliance requirements.
- Facilitate the use of risk management tools and templates to ensure efficient implementation.
- Assist Quality and Design Managers in resolving complex risk-related issues and implementing best practices.
Training and Education :
- Design and deliver training programs to enhance the skills of Quality Engineers and Design Engineers and other stakeholders in risk management methodologies.
- Foster a deep understanding of ISO 14971 and related standards across the organization.
Continuous Improvement and Collaboration :
- Identify opportunities to optimize risk management processes and recommend improvements.
- Work closely with cross-functional teams to ensure risk management integration into product lifecycle activities, including design, manufacturing, and post-market phases.
- Stay updated on evolving industry standards and share insights with relevant stakeholders.
Regulatory and Compliance Support :
- Support the BUs during internal and external audits related to risk management.
- With the support of regulatory team, monitor changes in regulations, assessing their impact on risk management processes and providing actionable guidance.
Performance Metrics and Reporting :
- Develop and maintain dashboards to track product risk management performance across BUs.
- Provide regular updates to leadership on risk management activities, key performance indicators, and areas for improvement.
(CDI)
Nemera is seeking a new Risk Management Specialist to join our R&D and Quality Teams, based in Lyon.
The Risk Management Specialist acts as a key enabler in the organization, harmonizing and standardizing risk management processes across Business Units. This role supports Quality, Design and manufacturing by providing standard tools, training, and guidance to ensure compliance with ISO 14971 and company standards. The Specialist fosters a culture of risk management excellence and drives continuous improvement initiatives.
This positions reports directly to the Quality Director.
Key Responsibilities
Risk Management System Harmonization :
- Develop, update and implement standardized risk management processes across all BUs.
- Create a Risk Management dictionary across all Bus aligned with existing
- Collaborate with Quality Managers to align risk management practices with corporate standards.
- Support the creation and maintenance of consistent Risk Management Files for all products.
Support and Enablement :
- Act as a resource for Quality, Design and BUs, providing guidance on risk assessments, FMEAs, and compliance requirements.
- Facilitate the use of risk management tools and templates to ensure efficient implementation.
- Assist Quality and Design Managers in resolving complex risk-related issues and implementing best practices.
Training and Education :
- Design and deliver training programs to enhance the skills of Quality Engineers and Design Engineers and other stakeholders in risk management methodologies.
- Foster a deep understanding of ISO 14971 and related standards across the organization.
Continuous Improvement and Collaboration :
- Identify opportunities to optimize risk management processes and recommend improvements.
- Work closely with cross-functional teams to ensure risk management integration into product lifecycle activities, including design, manufacturing, and post-market phases.
- Stay updated on evolving industry standards and share insights with relevant stakeholders.
Regulatory and Compliance Support :
- Support the BUs during internal and external audits related to risk management.
- With the support of regulatory team, monitor changes in regulations, assessing their impact on risk management processes and providing actionable guidance.
Performance Metrics and Reporting :
- Develop and maintain dashboards to track product risk management performance across BUs.
- Provide regular updates to leadership on risk management activities, key performance indicators, and areas for improvement.
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