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 Class IIa/IIb and/or Class III non-active orthopaedic medical devices.

• Execute technical and clinical assessments per relevant commission regulation codes, with the possibility of extending to dental devices.

• Detect and correct deviations from compliance requirements in device technical documentation.

• Assist with CE and UKCA marking processes within SGS.

• Provide training and qualification for junior staff and create thorough training materials.

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

• Reduce regulatory risks linked to medical device certification.

• Organize scheduled tasks to guarantee timely and efficient deliverables.

⛳️ Requirements

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

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

• Knowledge of essential standards applicable to 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 discipline such as medicine, biomedical engineering, or biomedical science, ideally with a focus on orthopaedic devices.

• Competence in modern electronic communication platforms.

• Strong proficiency in written English.

• Proven capacity for independent learning.

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

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

• CV must be submitted in English.

🏝️ Benefits

• Flexible schedule and work model.

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

• Comprehensive benefits platform.

• Opportunities for continuous learning, development, and growth.

• Multinational working environment.

• Fully remote work.