Senior Product Evaluator

hace 2 días

Madrid, Madrid, España SGS A tiempo completo
Job Description

Are you a seasoned professional with a strong background in product assessment and technical documentation review? Do you have a passion for ensuring compliance with EU regulations and standards? We are seeking a highly skilled Senior Product Evaluator to join our dynamic team at SGS.

Key Responsibilities:
  • Team Leadership: Support and guide a team of talented product assessors, providing guidance and mentorship to ensure their technical competence and success.
  • Technical Documentation Review: Conduct thorough reviews of technical documentation to ensure compliance with EU regulations and standards, including MDD/MDR.
  • Cross-Functional Collaboration: Work closely with cross-functional teams to increase efficiency and quality, ensuring seamless communication and collaboration.
  • Team Monitoring and Development: Monitor the team's technical competence, KPIs, and wellbeing, providing feedback and support to address any concerns.
  • Recruitment and Onboarding: Participate in the recruitment process, reviewing CVs and conducting interviews, and support the onboarding of new starters.
  • Training and Development: Develop and present training to others in SGS or externally, as needed, to ensure the team's technical competence and expertise.
  • Technical Queries and Support: Provide technical support and answer queries related to sales within the Active Medical Devices field.
  • Service Delivery: Ensure the highest level of service is provided throughout the SGS network, offering medical devices certification and stakeholders through efficient service delivery.
Requirements:
  • Experience: Prior experience as a product assessor/specialist/technical file reviewer within another notified body for active devices, conducting reviews against MDD and/or MDR.
  • Qualifications: 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.
  • Knowledge and Skills: 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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