Product Assessor for Orthopaedic (Notified Body)

Responsibilities

We are representing a confidential certification organization seeking a Product Assessor to conduct orthopaedic product assessments and technical documentation reviews. In this role, you will:

• Conduct thorough technical and clinical assessments of non-active orthopaedic medical devices in accordance with European Medical Device Regulation (EU MDR 2017/745) and UK Medical Device Regulation (UK MDR 2002) for Class IIa/IIb and Class III devices
• Review technical documentation to identify and rectify deviations from compliance with applicable requirements
• Support CE and UKCA marking activities within the notified body framework
• Contribute to training and qualification of junior staff and develop comprehensive training materials
• Communicate effectively with team members, clients, and stakeholders regarding product assessments, working to minimize regulatory risks associated with medical device certification
• Manage scheduled work diligently to maintain timeliness and efficiency in deliverables

What We're Looking For

Our client requires a highly qualified professional with:

• 4+ years of professional experience in the orthopaedic products sector or related fields, including design, manufacturing, auditing, or research
• A 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
• 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
• Understanding of essential standards for orthopaedic products
• Strong written English skills essential for reviewing and querying technical documentation assessment reports
• Proficiency in modern electronic communication platforms
• Demonstrated ability to learn independently
• Desirable: Prior experience conducting orthopaedic product assessments for a certification or notified body as a Technical Documentation Reviewer
• Desirable: Knowledge of European Medical Device Regulation (EU MDR 2017/745), UK Medical Device Regulation (UK MDR 2002), and familiarity with medical device codes as outlined in Commission Implementing Regulation (EU) 2017/2185

Location: Romania (fully remote; candidates from other countries may apply)

How We Work with You

When you apply through Get A Job.ai, our recruiting team will review your qualifications and conduct an initial screening. If there is a strong match, we will submit your profile to our client for consideration. Please do not contact the client directly, as all coordination will be managed through our talent team to ensure a professional and streamlined process.

Pay

Compensation details will be discussed during the screening process based on experience and qualifications.

Equal Employment Opportunity: Get A Job.ai is committed to inclusive hiring practices and works with clients who value diversity and provide equal opportunities to all qualified candidates.