Product Assessor for Orthopaedic (Notified Body) (Medical Devices)

Location: Fully remote; people from other countries can apply. The listed office location is Inward Way, Rossmore Business Park, Cheshire, United Kingdom.

Company

hirify.global is a global testing, inspection, and certification company with a worldwide network of offices and laboratories.

What you will do

• Conduct technical and clinical assessments of non-active orthopaedic medical devices, including Class IIa, Class IIb, and Class III devices.
• Review technical documentation against EU MDR 2017/745, UK MDR 2002, and applicable product standards.
• Identify documentation gaps and support corrective actions to maintain regulatory compliance.
• Support CE and UKCA marking activities and minimise regulatory risks associated with certification.
• Train and qualify junior staff by developing comprehensive training materials.
• Coordinate scheduled assessment work and communicate with clients, colleagues, and other stakeholders.

Requirements

• At least four years of professional experience in orthopaedic products or a related field, including at least two years in the design, manufacturing, or testing of orthopaedic products, or in a role requiring strong scientific knowledge of related technologies.
• Knowledge of essential standards for orthopaedic products.
• Master's degree, PhD, or equivalent qualification in medicine, biomedical engineering, biomedical science, or a related discipline, preferably focused on orthopaedic devices.
• Strong written English is required for reviewing and querying technical documentation assessment reports.
• Ability to learn independently and proficiency with modern electronic communication platforms.
• Knowledge of EU MDR 2017/745, UK MDR 2002, and MDA/MDN/MDS medical device codes is desirable.

Nice to have

• Previous experience conducting orthopaedic product assessments for a certification or notified body.
• Experience with dental devices and related regulatory classifications.

Culture & Benefits

• Flexible schedule and remote work model.
• Continuous learning through hirify.global University and Campus.
• Multinational working environment with colleagues across multiple continents.
• Comprehensive benefits platform.
• Supportive, diverse, and collaborative culture focused on professional development.