Medical Devices Certification Expert

hace 5 días


Madrid, Madrid, España Sgs Société Générale De Surveillance Sa. A tiempo completo

Company Overview

Sgs Société Générale De Surveillance Sa is a leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity.

About Us

We have 99,600 employees operating a network of 2,600 offices and laboratories, working together to enable a better, safer and more interconnected world.

Job Description

We are seeking an experienced Senior Product Assessor to join our dynamic team. As a Senior Product Assessor, you will play a critical role in ensuring compliance with EU regulations and standards.

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
  • Developing training and presenting it to others in SGS or externally as deemed necessary
  • Assisting with technical queries and those related to sales within the Active Medical Devices field
  • Ensuring that the highest level of service is provided throughout the SGS network offering medical devices certification and stakeholders through efficient service delivery

Requirements

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

Salary and Benefits

The estimated salary for this role is €80,000-€110,000 per annum, depending on experience. Our comprehensive benefits package includes health insurance, retirement savings plan, and paid time off.

About You

You will be a strong leader with excellent communication and interpersonal skills. You will have a proven track record of achieving results in a fast-paced environment and a passion for delivering high-quality work products.

Contact Information



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