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 orthopaedic devices.

• Conduct technical and clinical evaluations of non-active orthopaedic medical devices as per relevant commission regulation codes.

• Identify and address discrepancies in device technical documentation with respect to compliance requirements.

• Assist with CE and UKCA marking processes within SGS.

• Participate in the training and development of junior staff members.

• Create detailed training materials.

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

• Reduce regulatory risks linked to medical device certification.

• Organize work schedules to ensure timely and efficient delivery of outputs.

• Possibly expand expertise to include dental devices.

⛳️ Requirements

• Over 4 years of professional experience in the orthopaedic products industry or related domains, including design, manufacturing, auditing, or research.

• At least 2 years of direct involvement in the design, manufacture, and testing of orthopaedic products, or in positions requiring a comprehensive understanding of their scientific foundations.

• Familiarity with fundamental standards applicable to orthopaedic products.

• Previous experience 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 medicine, biomedical engineering, biomedical science, or a related field, preferably with an emphasis on orthopaedic devices.

• Competence in modern electronic communication tools.

• Strong English writing skills are crucial 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.

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

• CV must be submitted in English.

🏝️ Benefits

• Flexible working hours and model.

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

• Comprehensive benefits package.

• Multinational working environment.

• Opportunities for personal and professional development.

• Fully remote work arrangement.