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 .

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.

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