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 according to relevant commission regulation codes, with potential to broaden expertise into dental devices.

• Detect and correct any discrepancies from the required compliance standards in device technical documentation.

• Assist with CE and UKCA marking processes within SGS.

• Play a role in the training and development of junior staff.

• Create detailed training materials.

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

• Reduce regulatory risks linked to the certification of medical devices.

• Organize scheduled tasks to ensure timely and efficient delivery of work.

⛳️ Requirements

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

• At least 2 years of direct involvement in the design, manufacturing, and testing of orthopaedic products, or in roles that require a deep understanding of the scientific principles behind these products or technologies.

• Familiarity with essential standards for orthopaedic products.

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

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

• Skilled in using modern electronic communication tools.

• Strong proficiency in written English.

• Proven capability for independent learning.

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

• Familiarity with medical device codes MDA/MDN/MDS for MDR under Commission Implementing Regulation (EU) 2017/2185 is preferred.

• CV must be submitted in English.

🏝️ Benefits

• Flexible working hours and model.

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

• Comprehensive benefits platform.

• Multinational working environment.

• Opportunities to develop, enhance expertise, and achieve personal potential.