Senior Product Assessor Active Devices, Antwerp
il y a 2 semaines
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Client:Hudson Benelux
Location:Antwerp, Belgium
Job Category:Other
EU work permit required:Yes
Job Reference:0e7f57777edb
Job Views:23
Posted:23.01.2025
Expiry Date:09.03.2025
Job Description:Position
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 dive deep into the exciting world of Active Medical Devices.
Your responsibilities will include:
- Supporting and guiding your team of talented Product Assessors
- Conducting thorough technical documentation reviews and ensuring compliance with EU regulations and standards
- Collaborating with cross-functional teams to increase efficiency and quality
- Monitoring the team's technical competence, KPIs, and wellbeing, providing feedback and support when there are concerns
- Conducting recruitment, including reviewing CVs, undertaking interviews, and supporting onboarding of new starters
- Developing trainings and presenting them to others internally or externally as deemed necessary
- Assisting with technical queries related to sales within the Active Medical Devices field
- Ensuring that the highest level of service is provided throughout the SGS network offering medical devices certification and stakeholders through efficient service delivery
Qualifications
To be eligible for this role, you should have prior experience as a Product Assessor/Specialist/Technical File Reviewer within another Notified Body for active devices, conducting reviews against MDD and/or MDR.
Additionally, you must possess:
- 4 years of professional experience in the field of healthcare products or related activities, such as design, manufacturing, auditing, or research, of which 2 years in the design, manufacturing, testing, or use of the device or technology to be assessed or related to the scientific aspects to be assessed
- Active Medical Devices knowledge (monitoring equipment, therapeutic devices, devices utilizing radiation, stand-alone software devices, etc.) through designing, manufacturing, or testing of such devices
- Thorough knowledge and understanding of related standards: EN, EN, EN, etc.
- Good written English skills (as reports will be reviewed/queried in English)
- Knowledge of the following Technical File codes desirable (as per COMMISSION IMPLEMENTING REGULATION (EU) / of 23 November): MDA, MDA, MDA, MDA, MDA, MDA, MDA, MDA, MDA, MDA, MDA, MDA, MDA, MDA, MDA, MDA, MDA, MDA, MDA, MDA, MDA, and MDA
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