Product Assessor – Orthopaedic

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

📋 Description

• Perform evaluations of orthopaedic products and review technical documentation in compliance with EU MDR 2017/745 and UK MDR 2002.

• Carry out technical and clinical evaluations of non-active orthopaedic medical devices classified as Class IIa/IIb and/or Class III.

• Detect and correct any inconsistencies with relevant compliance requirements in device technical documentation.

• Assist with CE and UKCA marking processes within SGS.

• Aid in the training and development of junior personnel.

• Create detailed training materials.

• Engage in communication with team members, clients, and other relevant parties regarding product evaluations.

• Reduce regulatory risks linked to medical device certification.

• Organize work schedules to guarantee timely and effective deliverables.

• Potentially expand expertise to include dental devices.

⛳️ Requirements

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

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

• Knowledge of essential standards applicable to orthopaedic products.

• Previous experience in conducting orthopaedic product assessments 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, preferably with a focus on orthopaedic devices.

• Competence in current electronic communication tools.

• Excellent written communication skills in English.

• Proven ability for independent learning.

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

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

• Curriculum Vitae must be submitted in English.

🏝️ Benefits

• Flexible work schedule and model.

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

• Comprehensive benefits package.

• Open, friendly, and supportive workplace culture.

• Opportunities for personal growth, skill enhancement, and reaching one’s potential.

• Option for remote work arrangements.