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Product Assessor / Senior Product Assessor - Active Devices

Product Assessor / Senior Product Assessor - Active Devices

SGSmadrid, España
Hace más de 30 días
Descripción del trabajo

Overview

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 not only manage a small team of globally based Product Assessors but also dive deep into the exciting world of Active Medical Devices.

Responsibilities

  • 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 and providing feedback and support when there are concerns
  • Conduct recruitment including reviewing CVs and undertaking interviews and supporting with onboarding of new starters
  • Develop training and present the training to others in SGS or externally as deemed necessary
  • Assist with technical queries and those related to sales within the Active Medical Devices field
  • Ensure that the highest level of service is provided throughout the SGS network offering medical devices certification and stakeholders through efficient service delivery

Qualifications

For application please submit English CV.

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 :

  • Four years of professional experience in the field of healthcare products or related activities such as design, manufacturing auditing, or research, of which two years shall be in the design, manufacture, 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 60601, EN 62304, EN 62366, 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) 2017 / 2185 of 23 November 2017) : MDA0201-MDA0318

    • Additional Information

    Why SGS

  • Join a globally recognized and stable company a leader in the Testing Inspection and Certification (TIC) industry
  • Enjoy a flexible schedule and remote work model
  • Access SGS University and Campus for continuous learning options
  • Thrive in a multinational environment collaborating with colleagues from multiple continents
  • Benefit from our comprehensive benefits platform

    • Join Us : At SGS we are dedicated to fostering an open friendly and supportive culture that thrives on teamwork. We value diversity and provide endless opportunities to learn, grow your expertise and fulfill your potential.

    Remote Work : Yes

    Employment Type : Full-time

    Experience and Vacancy

  • Experience : years
  • Vacancy : 1

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