Product Assessor for Orthopaedic (Notified Body) in Ellesmere Port

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.