Senior Product Assessor

2 weeks ago

mumbai, India SGS Full time
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 not only manage a small team  of globally based Product Assessors  but also 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  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

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, 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 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. Apply now to be part of our motivated and dynamic team

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