Home
/
Comprehensive
/
Product Assessor - Active Devices
Product Assessor - Active Devices-December 2024
Columbus
Dec 25, 2025
About Product Assessor - Active Devices

  Company DescriptionWe are SGS - the world's leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 98,000employees operate a network of 2,650 offices and laboratories, working together to enable a better, safer and more interconnected world.Excited about a career at SGS?Join us as a Product Assessor - Active Devices in our successful certification division. As global leaders, SGS thrives on 100% passion, pride, and innovation. We embrace new ideas and are committed to helping you reach your full potential.Job DescriptionAs a Product Assessor in our Medical Device team, your role is pivotal. You'll conduct technical file reviews aligned with the European Medical Device Directive and Medical Device Regulation for Class IIa/IIb and/or Class III, ensuring both technical soundness and full compliance with requirements. Additionally, you'll actively contribute to training junior staff and developing training materials.Specifically, you will:* Ensure regulatory compliance in product technical file assessments under EU Medical Devices Directives and/or Regulations.* Conduct product assessments, primarily desk-based but occasionally on-site, following established procedures and maintaining a high standard of service delivery.* Sustain personal competence and development in specialized areas for consistent evaluation of product technical documentation.* Project manage assessments to maximize efficiencies, enhance client satisfaction, and ensure compliance with requirements.* Assist in addressing queries arising from product assessments.* Adhere to set Key Performance Indicators (KPIs) both individually and within a team.* Ensure the highest level of service delivery throughout the SGS network, contributing to efficient medical devices certification for stakeholders.Qualifications* 4 + Years of professional experience in healthcare products or related fields, encompassing roles in design, manufacturing, auditing, or research. Specifically, a minimum of two years should be dedicated to the design, manufacture, testing, or utilization of the device or technology under assessment, or be related to the scientific aspects being evaluated.* Active knowledge of Medical Devices, including monitoring equipment, therapeutic devices, devices utilizing radiation, and stand-alone software devices, acquired through hands-on experience in designing, manufacturing, or testing such devices.* Thorough familiarity with relevant standards such as EN 60601, EN 62304, EN 62366, demonstrating a comprehensive understanding of industry guidelines.* Strong written English skills are essential, as reports will undergo review and may be subject to queries in English.* Desirable familiarity with Technical File codes, including MDA0201, MDA0202, MDA0203, MDA0204, MDA0301, MDA0302, MDA0303, MDA0304, MDA0305, MDA0306, MDA0307, MDA0308, MDA0309, MDA0310, MDA0311, MDA0312, MDA0313, MDA0314, MDA0315, MDA0316, MDA0317, MDA0318Apply here: https://www.aplitrak.com/?adid=YmJnZW5lcmljLjAwNDQ1LjEwNTA4QHNnc25vcnRoYW1lcmljYWNvbXAuYXBsaXRyYWsuY29t

Comments
Welcome to zdrecruit comments! Please keep conversations courteous and on-topic. To fosterproductive and respectful conversations, you may see comments from our Community Managers.
Sign up to post
Sort by
Show More Comments
SIMILAR JOBS
LVN- Injection Center - Beverly Hills
Job Description Why work here? Beyond outstanding benefits, competitive salaries and health and dental insurance we take pride in hiring the best, most passionate employees. Our talented staff reflec
Named Account Representative
DescriptionAccount Representatives are responsible for retraining, upselling, initiating price improvement, and reducing lost business percentages year-over-year with existing accounts for a specific
Data Quality Developer- Oracle, Hadoop, ETL
Must have: Experience with basic Unix to be able to go debug logs, interpret/change config files etc. Experience working on any ETL tool ( in a data warehouse platform) or data governance platform. T
Software Engineer – DevOps
Job Number 24001155 Job Category Information Technology Location Marriott International HQ, 7750 Wisconsin Avenue, Bethesda, Maryland, United States Schedule Full-Time Located Remotely? Y Relocation?
Oracle NetSuite - Account Executive - Mid-market - High Tech West
Job Description About Oracle NetSuite Oracle NetSuite was founded in 1998 and is widely recognized as the first cloud computing software company. Having over 34,000 customers, we are a world leader i
Pantry Cook
Company Description Fairmont El San Juan Hotel, where lively vibes and peaceful ocean views meet. Located minutes from Old San Juan, on the award-winning Isla Verde Beach in Puerto Rico. The resort f
Full-Time Store Manager Trainee
As a Store Manager Trainee, you’ll train on all aspects of successfully running a store in preparation for running for your own store. You’ll be involved in supervising day-to-day store activities, e
Shift Manager
Hot burgers, cold shakes, and little moments of magic right in the neighborhood. At SONIC, we do things a little differently. We find the fun, the moment of chill in the every-day. Working at SONIC,
Assistant Junior High Football Coach
Assistant Junior High Football Coach JobID: 599 Position Type: Athletics/Activities/ Coaching Date Posted: 1/5/2024 Location: West Burlington Junior/Senior High    Description:The West Burlington Ind
Writer/Editor
Job ID359188 LocationTwin Cities Job FamilyMarketing & Communications Full/Part TimeFull-Time Regular/TemporaryRegular Job Code8342EW Employee ClassCivil Service About the Job OVERVIEW Do you wri
Copyright 2023-2025 - www.zdrecruit.com All Rights Reserved