Product Assessor – Orthopaedic

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🔥 0 minutes ago

🇵🇱 Poland – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

✨ Assessor

👻 Ghost score 12%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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SGS

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1878

💼 Consulting

🏥 Healthcare

🍽️ Food & Beverage

Consulting • Healthcare • Food & Beverage

SGS is the world's leading Testing, Inspection, and Certification (TIC) company, providing a comprehensive range of services designed to assure quality and integrity across various sectors. SGS is focused on sustainability, offering climate action services and an all-encompassing ESG portfolio under its IMPACT NOW suite. The company has ambitious targets for growth by 2027, driven by its strategy to address global megatrends. SGS operates globally, providing business assurance, connectivity and products, digital trust, health and nutrition, and solutions for industries and the environment.

📋 Description

• Conduct thorough technical and clinical assessments of non-active orthopaedic medical devices under relevant commission regulation codes • Review technical documentation for Class IIa/IIb and/or Class III devices • Identify and rectify deviations from applicable compliance requirements • Support CE and UKCA marking activities within SGS • Contribute to training and qualification of junior staff • Develop comprehensive training materials • Communicate with team members, clients, and other stakeholders regarding product assessments • Minimise regulatory risks associated with medical device certification • Manage scheduled work to maintain timely and efficient deliverables • Potentially extend expertise to dental devices

🎯 Requirements

• 4+ years of professional experience in the orthopaedic products sector or related fields, covering design, manufacturing, auditing, or research • Minimum of two years directly involved in the design, manufacturing, and testing of orthopaedic products, or in roles requiring deep understanding of the scientific principles underlying these products or technologies • Understanding of essential standards for orthopaedic products • Prior experience conducting orthopaedic product assessments for a Certification/Notified Body as a Technical Documentation Reviewer is advantageous • Master's degree, PhD, or equivalent in a related discipline, such as medicine, biomedical engineering, or biomedical science, preferably focused on orthopaedic devices • Proficiency in modern electronic communication platforms • Strong written English skills essential for reviewing and querying Technical Documentation assessment reports • Demonstrated ability to learn independently • Knowledge of EU MDR 2017/745 and UK MDR 2002 is desirable • Familiarity with medical device codes MDA/MDN/MDS for MDR under Commission Implementing Regulation (EU) 2017/2185 is desirable • CV must be submitted in English

🏖️ Benefits

• Open corporate and international culture • Dynamic work environment in a leading global company • Future-oriented work environment • Employee development and long-term support • Flexible schedule and work model • Access to SGS University and Campus for continuous learning options • Multinational environment with colleagues from multiple continents • Comprehensive benefits platform • Open, friendly, and supportive culture • Opportunities to learn, grow expertise, and fulfill potential