Product Assessor, Orthopaedic

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

📋 Description

• Perform evaluations of orthopaedic products and review technical documentation as per EU MDR 2017/745 and UK MDR 2002 regulations.

• Evaluate non-active orthopaedic medical devices according to relevant commission regulation codes, with the possibility of expanding to dental devices.

• Detect and correct any deviations from the applicable compliance standards in device technical documentation.

• Assist with CE and UKCA marking processes within SGS.

• Play a role in training and qualifying junior team members.

• Create thorough training materials.

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

• Reduce regulatory risks linked to medical device certification.

• Manage assigned tasks to ensure timely and efficient outputs.

⛳️ Requirements

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

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

• Knowledge of essential standards for orthopaedic products.

• Previous experience in conducting orthopaedic product evaluations 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 focused on orthopaedic devices.

• Competence in modern electronic communication tools.

• Excellent written English skills.

• Proven ability to learn independently.

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

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

• CV must be provided in English.

🏝️ Benefits

• Flexible scheduling and work arrangements.

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

• Comprehensive benefits package.

• Opportunities to enhance skills, develop expertise, and reach your full potential.

• An open, welcoming, and supportive workplace culture.

• Fully remote work arrangement.