Product Assessor – Orthopaedic

This is a fully remote position, open to applicants in Poland.

📋 Description

• Perform assessments of orthopaedic products and review technical documentation in accordance with EU MDR 2017/745 and UK MDR 2002.

• Evaluate non-active orthopaedic medical devices classified as Class IIa/IIb and/or Class III in line with relevant commission regulation codes.

• Detect and correct any deviations from the applicable compliance requirements within device technical documentation.

• Assist with CE and UKCA marking processes at SGS.

• Aid in the training and development of junior staff members.

• Create detailed training materials.

• Liaise with team members, clients, and other stakeholders regarding product evaluations.

• Reduce regulatory risks linked to medical device certification.

• Organize scheduled tasks to guarantee timely and effective deliverables.

• May extend expertise to include dental devices.

⛳️ Requirements

• Over 4 years of professional experience in the orthopaedic products sector or related areas, encompassing design, manufacturing, auditing, or research.

• A minimum of two years of hands-on experience in the design, manufacturing, and testing of orthopaedic products, or in positions necessitating a profound understanding of the scientific principles behind these products or technologies.

• Familiarity with essential standards pertaining to orthopaedic products.

• Previous experience conducting orthopaedic product assessments for a Certification/Notified Body is a plus.

• A Master's degree, PhD, or equivalent in a related field such as medicine, biomedical engineering, or biomedical science, ideally with a focus on orthopaedic devices.

• Competency in modern electronic communication tools.

• Strong written English proficiency is crucial for reviewing and questioning Technical Documentation assessment reports.

• Proven capacity for independent learning.

• Knowledge of EU MDR 2017/745 and UK MDR 2002 is advantageous.

• Acquaintance with medical device codes MDA/MDN/MDS for MDR is preferred.

• CV must be submitted in English.

🏝️ Benefits

• Flexible schedule and work arrangements.

• Access to SGS University and Campus for ongoing learning opportunities.

• Comprehensive benefits platform.

• Opportunities to enhance skills, develop expertise, and realize potential.

• Multinational work environment.

• Long-term support for employee development.