Risk Manager Medical Devices FMX
Risk Manager Medical Devices FMX
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Job Description
Risk Manager (Medical Devices) F/M/X
(CDI)
Nemera is seeking a new Risk Manager to join our R&D and Quality Teams based in Lyon.
The Risk Manager 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 riskrelated 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 crossfunctional teams to ensure risk management integration into product lifecycle activities including design manufacturing and postmarket 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.
Qualifications :
Education and Experience:
- Masters degree in Engineering Design Quality or a related field; advanced degree preferred.
- Minimum 5 years of experience in risk management preferably in medical device or pharmaceutical industries.
Skills and Knowledge:
- Strong expertise in ISO 14971 and risk management tools (e.g. FMEA FTA).
- Proficiency in training and mentoring crossfunctional teams.
- Excellent organizational and collaboration skills with the ability to work across multiple BUs.
- Knowledge of quality systems design controls and regulatory requirements for medical devices.
Preferred:
- Experience in harmonizing risk management processes across global teams.
- Familiarity with usability and human factors engineering.
- Certifications in Risk Management Quality Engineering or Six Sigma.
Languages:
Fluent in English (as it is our company language) French is a plus.
You will be successful here if you are:
Passionate about growing a business
Enjoy working as a team
Proud to make products that improve patients lives
And go the extra mile to deliver on your commitments
Please send your resume in English
At Nemera our patientfirst purpose is at the heart of who we are. We foster a culture of care that gives us the power to do whats right for patients customers and our people. As a team were wired for growth. Passionate. Highenergy. Highimpact.
We are committed to fostering a work environment that values and celebrates difference which is fair and equitable and is enriched by openness curiosity and accountability. Everyone at Nemera has a role to play and Diversity and Inclusion is everyones responsibility. Because when everyone is included Nemera wins!
That is why Nemera is an equal opportunity employer and in accordance with our diversity policy we review all qualified applications including those of people with disabilities.
We look forward to receiving your application (resume submitted in English is appreciated). We offer varied jobs job in an international group if you want to discover more about Nemera please look at our website
Know someone at Nemera We have a Referral Program so be sure to have them submit you as a referral prior to applying for this position!
If you think your profile could match apply today to begin your career with Nemera. Send us your application!
Nemera is an equal opportunity employer and in accordance with our diversity policy we review all qualified applications including those of people with disabilities.
Informations supplmentaires :
Our Recruitment Process
We believe in a transparent and straightforward recruitment process to ensure a great fit for both you and our team.
Heres what you can expect:
CV Review: Upon receiving your CV our Talent Acquisition Team will review it to assess your qualifications for the role.
Initial Screening: If your profile matches our requirements youll be invited for an initial screening call with a member of our Talent Acquisition Team.
Interview with Hiring Manager: After the initial screening youll have an interview with the Hiring Manager to discuss your experience skills and fit for the role in more detail.
Interview with N2: Following the Hiring Manager interview youll meet with the next level of management (N2 for further evaluation.
HR Manager Interview: The final step involves an interview with our HR Manager to discuss company culture benefits and other HRrelated topics.
Offer: If all goes well youll receive an offer to join our team!
Chez Nemera nous valorisons la diversit et linclusion et nous nous engageons crer un environnement de travail o tous les employs sont traits avec dignit et respect.
Nous sommes fiers dtre un employeur offrant lgalit des chances et nous encourageons les candidatures de toutes les origines genres orientations sexuelles ges et capacits.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
