Product Assessor, Orthopaedic

This is a fully remote position, open to applicants in Poland, +1 more country.

📋 Description

• Perform detailed technical and clinical evaluations of non-active orthopedic medical devices in accordance with relevant commission regulation codes.

• Assess technical documentation for Class IIa/IIb and/or Class III medical devices.

• Detect and correct non-compliance issues with applicable regulations.

• Assist with CE and UKCA marking initiatives at SGS.

• Aid in the training and qualification of junior personnel.

• Create thorough training materials.

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

• Reduce regulatory risks related to medical device certification.

• Organize work schedules to ensure timely and effective deliverables.

⛳️ Requirements

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

• At least two years of direct involvement in the design, manufacturing, and testing of orthopedic products, or in positions requiring a thorough understanding of the scientific principles related to these products or technologies.

• Familiarity with essential standards pertaining to orthopedic products.

• Previous experience conducting orthopedic product evaluations for a Certification/Notified Body as a Technical Documentation Reviewer is a plus.

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

• Competence in modern electronic communication tools.

• Strong written English proficiency necessary for reviewing and querying Technical Documentation assessment reports.

• Proven ability to learn independently.

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

• Understanding of medical device codes MDA/MDN/MDS for MDR as specified in Commission Implementing Regulation (EU) 2017/2185 is preferred.

• CV must be submitted in English.

🏝️ Benefits

• Flexible work schedule and model.

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

• Comprehensive benefits platform.

• Multinational environment with colleagues from various continents.

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