Product Assessor, Orthopaedic

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

📋 Description

• Perform assessments of orthopaedic products and review technical documentation.

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

• Detect and correct discrepancies in device technical documentation relative to applicable requirements.

• Assist with CE and UKCA marking processes within SGS.

• Aid in the training and development of junior team members.

• Create thorough training materials.

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

• Reduce regulatory risks tied to medical device certification.

• Organize scheduled tasks to ensure timely and efficient deliverables.

⛳️ Requirements

• A minimum of 4 years of professional experience in the orthopaedic products domain 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 necessitating a comprehensive understanding of the scientific principles related to these products or technologies.

• Knowledge of essential standards relevant 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 discipline such as medicine, biomedical engineering, or biomedical science, ideally focused on orthopaedic devices.

• Competence in modern electronic communication platforms.

• Strong written English skills are critical for reviewing and inquiring about Technical Documentation assessment reports.

• Proven ability to learn independently.

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

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

• CV must be submitted in English.

🏝️ Benefits

• Flexible scheduling and work arrangements.

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

• Comprehensive benefits platform.

• Opportunities for learning, skill enhancement, and personal development.

• An open, friendly, and supportive workplace culture.

• A teamwork-oriented environment.

• Opportunities for diversity and development.