Product Assessor, Orthopaedic

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

📋 Description

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

• Evaluate non-active orthopaedic medical devices under the relevant commission regulation codes, with a potential extension to dental devices.

• Detect and correct discrepancies in compliance requirements within device technical documentation.

• Assist with CE and UKCA marking processes at SGS.

• Play a role in the training and qualification of junior team members.

• Create thorough training materials.

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

• Mitigate regulatory risks related to medical device certification.

• Organize work schedules to ensure timely and efficient deliverables.

⛳️ Requirements

• Minimum of 4 years of professional experience in the orthopaedic products industry or related fields, encompassing design, manufacturing, auditing, or research.

• At least 2 years of direct involvement in the design, manufacturing, and testing of orthopaedic products, or in positions requiring a thorough understanding of the underlying scientific principles or technologies.

• Knowledge of essential standards applicable to orthopaedic products.

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

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

• Competence in modern electronic communication tools.

• Strong proficiency in written English.

• Capability for self-directed learning.

• Familiarity with EU MDR 2017/745 and UK MDR 2002 is preferred.

• Acquaintance 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

• Engaging work atmosphere within a prominent global organization.

• Progressive work environment focused on the future.

• Support for long-term employee development.

• Flexible work schedule and model.

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

• Multinational workplace with colleagues from various continents.

• Comprehensive benefits platform.

• Opportunities for learning, expertise development, and personal growth.