Senior Product Assessor

hace 3 semanas

Barajas de Melo, España SGS A tiempo completo

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 totake your career to the next level? If you have a strong background as aProduct Assessorwithin an EUnotified bodyconducting MDD/MDR technical documentation review, then we have anexhilarating opportunityfor you

Join ourdynamic team at SGSand become aSenior Product Assessor - Active Devices. This role will allow you to make asignificant impactin the field ofcertification.

As a member of ourMedical Device team, you will not onlymanage a small teamof globally basedProduct Assessorsbut alsodive deepinto the exciting world ofActive Medical Devices.

Your responsibilities will include:

  • Supporting and guiding your team of talentedProduct Assessors
  • Conducting thorough technical documentation reviews and ensuringcompliance with EU regulations and standards.
  • Collaborating withcross-functional teamsto increaseefficiency and quality
  • Monitoring the team'stechnical competence, KPIs, and wellbeingand providing feedback and support when there are concerns.
  • Conductrecruitment, including reviewing CVs and undertaking interviews and supporting withonboarding of new starters
  • Developtrainingand present the training to others in SGS or externally as deemed necessary.
  • Assist withtechnical queriesand those related tosales within the Active Medical Devices field.
  • Ensure that thehighest level of service is providedthroughout the SGS network offering medical devicescertificationand stakeholders throughefficient service delivery.

Qualifications


To be eligible for this role, you should have prior experience as aProduct Assessor/Specialist/Technical File Reviewerwithin anotherNotified Bodyfor active devices, conducting reviewsagainst MDD and/or MDR.

Additionally, you must possess:

  • Four years ofprofessional experiencein the field ofhealthcare productsor 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 relatedstandards: EN 60601, EN 62304, EN 62366, etc.;
  • Good writtenEnglish skills(as reports will be reviewed/queried in English); Knowledge of the followingTechnical File codes desirable(as per COMMISSION IMPLEMENTING REGULATION (EU) 2017/2185 of 23 November 2017):MDA0201, MDA0202, MDA0203, MDA0204, MDA0301, MDA0302, MDA0303, MDA0304, MDA0305, MDA0306, MDA0307, MDA0308, MDA0309, MDA0310, MDA0311, MDA0312, MDA0313, MDA0314, MDA0315, MDA0316, MDA0317, and 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 hybridwork 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. Apply now to be part of our motivated and dynamic team

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