Product Assessor, Orthopaedic

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

📋 Description

• Perform in-depth technical and clinical evaluations of non-active orthopaedic medical devices.

• Examine technical documentation for Class IIa/IIb and/or Class III devices in accordance with EU MDR 2017/745 and UK MDR 2002.

• Detect and correct non-compliance issues related to applicable regulations.

• Assist with CE and UKCA marking processes within SGS.

• Aid in the training and development of junior personnel.

• Create detailed training materials.

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

• Reduce regulatory risks associated with medical device certification.

• Organize scheduled tasks to ensure timely and efficient delivery.

• Possibly extend expertise to dental devices.

⛳️ Requirements

• Over 4 years of professional experience in the orthopaedic products sector or related areas.

• A minimum of 2 years of direct involvement in the design, manufacturing, and testing of orthopaedic products, or in roles requiring a profound understanding of their scientific principles.

• Knowledge of essential standards for orthopaedic products.

• Master's degree, PhD, or equivalent in a related field such as medicine, biomedical engineering, or biomedical science, preferably specializing in orthopaedic devices.

• Competence in modern electronic communication tools.

• Strong proficiency in written English.

• Capability to learn autonomously.

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

• Awareness of MDA/MDN/MDS medical device codes is desirable.

• Experience as a Technical Documentation Reviewer for a Certification/Notified Body is beneficial but not mandatory.

• CV must be submitted in English.

🏝️ Benefits

• Flexible scheduling and work arrangements.

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

• Multinational workplace with colleagues from various continents.

• Comprehensive benefits platform.

• Support for employee growth within the organization.

• Dynamic work environment in a leading global firm.

• Open, friendly, and supportive company culture.

• Opportunities to learn, enhance expertise, and achieve potential.