Product Assessor / Senior Product Assessor - Active Devices

SGS; Marseille; Hybride; EUR 60 000 - 80 000; Plein temps

Résumé du poste

A leading testing and certification company in Marseille is looking for a Senior Product Assessor - Active Devices. The role involves managing a team, conducting technical reviews, and ensuring compliance with EU regulations for healthcare products. Ideal candidates should have a solid background in active medical devices and strong English communication skills. The position offers career growth in a dynamic and supportive environment.

Prestations

Flexible scheduling

Remote work options

Continuous learning through SGS University

Comprehensive employee benefits

Qualifications

• Prior experience as a Product Assessor/Specialist/Technical File Reviewer within a Notified Body for active devices.
• At least four years of professional experience in healthcare products, two years in related device assessment.
• Thorough understanding of standards such as EN 60601, EN 62304, EN 62366.

Responsabilités

• Supporting and guiding a team of Product Assessors.
• Conducting technical documentation reviews for compliance with EU regulations.
• Training sessions internally and externally as needed.

Connaissances

Technical documentation review

Knowledge of Active Medical Devices

Strong written English skills

Description du poste

We are SGS – the world's leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer and more interconnected world.

Job Description

Are you ready to take your career to the next level? If you have a strong background as a Product Assessor within an EU notified body conducting MDD / MDR technical documentation review, then we have an exhilarating opportunity for you!

Join our dynamic team at SGS and become a Senior Product Assessor - Active Devices. This role will allow you to make a significant impact in the field of certification.

As a member of our Medical Device team, you will manage a small team of globally based Product Assessors and work within the exciting field of Active Medical Devices.

Your responsibilities will include :

• Supporting and guiding your team of Product Assessors
• Conducting technical documentation reviews to ensure compliance with EU regulations and standards
• Collaborating with cross-functional teams to improve efficiency and quality
• Monitoring team members' technical competence, KPIs, and wellbeing, providing feedback and support
• Participating in recruitment activities, including reviewing CVs, conducting interviews, and onboarding new staff
• Developing and delivering training sessions internally and externally as needed
• Addressing technical queries and supporting sales activities within the Active Medical Devices field
• Providing high-quality service throughout the SGS network for medical device certification and stakeholder engagement

Qualifications

To apply, please submit your CV in English.

Candidates should have prior experience as a Product Assessor / Specialist / Technical File Reviewer within a Notified Body for active devices, with experience reviewing against MDD and/or MDR.

Additional requirements include :

• At least four years of professional experience related to healthcare products, including design, manufacturing, testing, or research, with at least two years in the design, manufacture, testing, or scientific assessment of relevant devices or technologies
• Knowledge of Active Medical Devices, including monitoring, therapeutic, radiation, and software devices, through experience in designing, manufacturing, or testing
• Thorough understanding of standards such as EN 60601, EN 62304, EN 62366
• Strong written English skills for report review and communication
• Knowledge of relevant Technical File codes (e.g., MDA0201 to MDA0318) as per EU regulations is desirable

Additional Information

Why SGS?

• Join a globally recognized and stable leader in the TIC industry
• Enjoy flexible scheduling and remote work options
• Access continuous learning through SGS University and Campus
• Work in a multicultural environment with colleagues worldwide
• Benefit from comprehensive employee benefits

Join Us : At SGS, we foster an inclusive, friendly, and supportive culture that emphasizes teamwork. We value diversity and offer numerous opportunities for learning, growth, and reaching your potential.