Senior Product Assessor, Active Devices

4 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.

It is remote based, and we are open to candidates located everywhere across Europe and India. But they must hold a valid work permit for their country of residency.

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 code is mandatory (as per COMMISSION IMPLEMENTING REGULATION (EU) 2017/2185 of 23 November 2017) : MDA 0314 Knowledge of the following Technical File code is would be a great addition (as per COMMISSION IMPLEMENTING REGULATION (EU) 2017/2185 of 23 November 2017) : MDA 0203, MDA 0301, MDA 0302, MDA 0305, MDA 0306, MDA 0312, MDA 0317

Please submit your CV in English.

  • Senior Product Assessor, Active Devices

    3 weeks ago

    Mumbai, Maharashtra, India SGS Full time

    Company Description 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 At SGS we have an open corporate...

  • Senior Product Assessor, Active Devices

    1 week ago

    Mumbai, Maharashtra, India SGS Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Company Description 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.At SGS, we have an open...

  • Senior Product Assessor, Active Devices

    3 weeks ago

    Mumbai, India Sgs Infratech Full time

    Job Description - 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 teams technical competence, KPIs, and wellbeing and providing feedback...

  • Medical Assessor

    7 days ago

    Bengaluru, Delhi, Mumbai, NCR, India Sofomation Energy Full time ₹ 15,00,000 - ₹ 25,00,000 per year

    OPENING FOR A WELL KNOWN OIL AND GAS COMPANY In MIDDLE EAST:Position: Medical Devices-Assessor/ AuditorExperience:Require about 10 years of professional experience in relevant field of healthcare products or related activities e.g.: work in medical devices industry such as research and development, manufacturing, quality management, regulatory affairs.5 +...

  • Freelancer Assessors Required for Beauty

    1 week ago

    Mumbai, India Diversified Business Solutions Pvt Ltd Full time

    Require Part Time Invigilator/Assessor in Skill India Govt. for Beauty & Wellness sector. We are an assessment agency responsible for conducting exams and empanelled with Beauty & Wellness Sector Skill Council ,Tourism & Hospitality Sector Skill Council, Sports, Physical Education Fitness & Leisure Skills Council, etc. **Responsibilities and Duties** **#...

  • Senior Planning Advisor

    2 days ago

    Mumbai, Maharashtra, India LRQA Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Role purpose:Proactively responds to complex customer queries as required and supports less experienced colleagues..Responsible for planning complex visits/activities, ensuring the right assessors are being used and optimised in the right place, and at the right cost to achieve utilisation targets and compliance with accreditation requirements.Supports less...

  • Senior Planning Advisor

    4 weeks ago

    Mumbai, India LRQA Full time

    Job ID:Location:Mumbai: Solitaire Corporate Park  Position Category:Customer Service Position Type:Employee Regular Who are LRQA? LRQA stands for dedication to clients, market firsts, and deep expertise in risk management. We’ve grown to become a leading global assurance provider, bringing together outstanding expertise in certification, customised...

  • Senior Planning Advisor

    1 week ago

    Mumbai, India LRQA Full time

    Job Description Who are LRQA LRQA stands for dedication to clients, market firsts, and deep expertise in risk management. We've grown to become a leading global assurance provider, bringing together outstanding expertise in certification, customised assurance, cybersecurity, inspection and training. What do we do We help our clients negotiate a rapidly...

  • Senior Planning Advisor

    21 hours ago

    Mumbai, Maharashtra, India LRQA group Full time ₹ 12,00,000 - ₹ 24,00,000 per year

    Job ID:42843Location:Mumbai: Solitaire Corporate ParkPosition Category:Customer ServicePosition Type:Employee RegularWho are LRQA?LRQA stands for dedication to clients, market firsts, and deep expertise in risk management. We've grown to become a leading global assurance provider, bringing together outstanding expertise in certification, customised...

  • Senior R&D Engineer – Medical Devices

    2 weeks ago

    Mumbai, Maharashtra, India Tek Support Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Job Title: Senior R&D Engineer – Medical DevicesLocation:Mumbai, INDEmployment type:Part-timePosition Summary:We are seeking an experiencedR&D Engineer Trainer with 10+ years in the medical device industryto lead the design, development, and optimization of innovative medical technologies. The role involves driving new product development (NPD) from...