Product Assessor for Orthopaedic (Notified Body)

SGS; Warszawa; On-site; PLN 180,000 - 240,000; Full time

Job summary

SGS is seeking an experienced Product Assessor for Orthopaedic devices to conduct technical and clinical assessments under EU MDR and UK MDR. You will review documentation, support CE/UKCA marking, and contribute to training while ensuring timely delivery in a global, multi-disciplinary environment.

The role requires a strong background in orthopaedic devices, regulatory knowledge, and excellent English communication within SGS’s international team.

Qualifications

• 4+ years of professional experience in orthopaedic products sector or related fields.
• Understanding of essential standards for orthopaedic products.
• Proficiency in modern electronic communication platforms.
• Strong written English skills for reviewing Technical Documentation reports.

Responsibilities

• Conduct thorough technical and clinical assessments of non-active orthopaedic medical devices under relevant regulations.
• Identify and rectify deviations in device technical documentation for compliance.
• Provide support for CE and UKCA marking activities within SGS.
• Contribute to training and qualification of junior staff and develop training materials.
• Communicate with team, clients, and stakeholders to minimise regulatory risks in medical device certification.
• Manage scheduled work to ensure timely deliverables.

Skills

English proficiency

Independent learner

Regulatory knowledge

Strong written communication

Education

Master's or PhD in biomedical/medical engineering

Job description

Product Assessor for Orthopaedic (Notified Body)

• Full-time

We are SGS - the world's leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer and more interconnected world.

At SGS, we have an open corporate and international culture. We offer a dynamic work environment in a leading global company. Our high professional standards and our sustainability approach guarantee you a future-oriented work environment. We invest in our employees for the long term and are committed to supporting your development within the company. Our business principles include: Integrity, Health, Safety & Environment, Quality & Professionalism, Respect, Sustainability, and Leadership.

As a Product Assessor, you will play a pivotal role in conducting orthopaedic product assessments and technical documentation reviews in strict adherence to European Medical Device Regulation (EU MDR 2017/745) and the UK Medical Device Regulation (UK MDR 2002) and for Class IIa/IIb and/or Class III devices.

Key Responsibilities:

• Conduct thorough technical and clinical assessments of non-active orthopaedic medical devices under relevant commission regulation codes, with potential to extend expertise to dental devices.
• Identify and rectify instances where device technical documentation deviates from compliance with applicable requirements.
• Provide support for CE and UKCA marking activities within SGS.
• Contribute to the training and qualification of junior staff and develop comprehensive training materials.
• Communicate effectively with team members, clients, and other stakeholders regarding product assessments, working diligently to minimise regulatory risks associated with medical device certification.
• Ensuring diligent management of scheduled work to maintain timeliness and efficiency in deliverables.

We are seeking an experienced candidate with:

• 4+ years of professional experience in the orthopaedic products sector or related fields, covering roles in design, manufacturing, auditing, or research. Crucially, a minimum of two years should be directly involved in the design, manufacturing, and testing of orthopaedic products, or in roles that require a deep understanding of the scientific principles underlying these products or technologies.
• Understanding of essential standards for orthopaedic products.
• Prior experience in conducting orthopaedic product assessments for a Certification/Notified Body (acting as a Technical Documentation Reviewer) is advantageous.
• A Master's degree, PhD, or equivalent in a related discipline, such as medicine, biomedical engineering, or biomedical science, preferably with a focus 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.
• Desirable: Regulatory Acumen - knowledge of the European Medical Device Regulation (EU MDR 2017/745) and the UK Medical Device Regulation (UK MDR 2002) and familiarity with medical device codes MDA/MDN/MDS for MDR as outlined in Commission Implementing Regulation (EU) 2017/2185.

Why SGS?

• Join a globally recognized and stable company, a leader in the Testing, Inspection, and Certification (TIC) industry.
• Enjoy a flexible schedule andwork model.
• Access SGS University and Campus for continuous learning options.
• Thrive in a multinational environment, collaborating with colleagues from multiple continents.
• Benefit from our comprehensive benefits platform.

Join Us:

At SGS, we are dedicated to fostering an open, friendly, and supportive culture that thrives on teamwork. We value diversity and provide endless opportunities to learn, grow your expertise, and fulfill your potential.