Risk Management Specialist F/mx

**Description de l'entreprise**
With sales of €600m and 3,000 employees worldwide, Nemera is one of the leading global manufacturers of complex drug delivery systems for the pharmaceutical industry, offering to patients a broad product portfolio which includes inhalation devices, injection devices, nasal and dermal pumps and ophthalmic delivery devices. Nemera has built very long lasting, strong relationships with the leading global pharmaceutical companies globally by providing high quality development, industrialization and manufacturing services. Nemera develops and manufactures its own IP product platforms but also offers also fully custom developments and contract manufacturing.

Nemera’s manufacturing sites are located in the US, France, Germany, Brazil and Poland. The headquarters and Innovation Center for early device design and development are located in France (Lyon).
We have big ambitions at Nemera We are growing our franchises and strengthening our capabilities.
**Description du poste** 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.

**Qualifications** Education and Experience**:

- Master’s 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 cross-functional 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 patient-first purpose is at the heart of who we are. We foster a culture of care that gives us the power to do what’s right — for patients,