Product Assessor – Orthopaedic

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

📋 Description

• Perform comprehensive technical and clinical evaluations of non-active orthopaedic medical devices in accordance with applicable commission regulation codes.

• Analyze technical documentation for Class IIa/IIb and/or Class III devices.

• Detect and correct non-compliance issues with relevant regulatory requirements.

• Assist with CE and UKCA marking processes within SGS.

• Play a role in the training and development of junior personnel.

• Create detailed training resources.

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

• Mitigate regulatory risks linked to medical device certification.

• Organize scheduled tasks to ensure timely and efficient outcomes.

• Potentially leverage expertise in 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 two years of direct involvement in the design, manufacturing, and testing of orthopaedic products, or in roles that require a thorough understanding of the scientific principles governing these products or technologies.

• Familiarity with essential standards for orthopaedic products.

• Previous experience in conducting orthopaedic product evaluations for a Certification/Notified Body as a Technical Documentation Reviewer is beneficial.

• A Master's degree, PhD, or equivalent in a relevant field, such as medicine, biomedical engineering, or biomedical science, ideally with a focus on orthopaedic devices.

• Proficient in modern electronic communication tools.

• Strong written English 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.

• Familiarity with medical device codes MDA/MDN/MDS for MDR under Commission Implementing Regulation (EU) 2017/2185 is a plus.

• CV must be submitted in English.

🏝️ Benefits

• Open corporate and international culture.

• Dynamic work environment in a leading global organization.

• Future-oriented work setting.

• Employee development and long-term support.

• Flexible schedule and work model.

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

• Multinational environment with colleagues from various continents.

• Comprehensive benefits platform.

• Open, friendly, and supportive culture.

• Opportunities to learn, enhance expertise, and reach full potential.