SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 89,000 employees, SGS operates a network of over 2,600 offices and laboratories around the world.

The Product Assessor (Orthopedic & Dental) will conduct technical file reviews of Class 11a/11b and/or Class III and approve or raise queries based on technical and procedural knowledge. They will ensure reviews are technically sound and in compliance with all applicable regulations, standards, guidelines, and competent authority expectations. The Product Assessor will ensure that the highest level of service is provided through efficient service delivery and those customer requirements are met while adhering to SGS Policies, procedures, and processes.  Act as a support/leader to the defined group in terms of technical assistance, facilitate training, communication, assistance with widening the codebase.

• Ensure regulatory compliance of technical file reviews under applicable EU Medical Devices Directives and /or Regulations
• Conduct reviews (primarily desk-based, but occasionally may be on-site) in accordance with established procedures, maintaining a high standard of service delivery.
• Maintain personal competence and development in qualified specialist areas on an ongoing basis
• Project manage reviews as appropriate, to maximize efficiencies, enhance client satisfaction and ensure compliance with standards
• Support/assist on queries raised from the review
• Work at all times to adhere to KPI’s set as an individual and within a team
• To ensure personal competency is maintained to be able to review technical files and technical documentation
• Maintenance of MDD/MDR or IVD/IVR Product Assessor status
• Ensure the group has a good level of understanding of the process/procedures, technical updates, correct training, technical support, and a good level of communication/group working
• Ensure that the highest level of service is provided throughout the SGS network offering Medical Devices certification and final customers through efficient service delivery
• Ensure full compliance with the Company’s Code of Integrity & Professional Conduct, and act in accordance with SGS UK’s Equality & Diversity Policy and ensure others do so
• At all times, adopt a safe behavior by exercising due regard for the health and safety of yourself, colleagues, and clients, in line with the Company’s policies and procedures
• Adheres to internal standards, policies, and procedures
• Performs other duties as assigned

Education and Experience

• Bachelor’s degree in a related discipline (i.e., medicine, pharmacy, engineering, or other relevant sciences (Required)
• Minimum 4 years of experience in the field of healthcare products or related industry (manufacturing, auditing, or research) (Required)
• Minimum 2 years in the design, manufacture, testing, or use of the device or technology to be assessed or related to the scientific aspects to be assessed (Required)
• Have a broad range of codes and previous Technical File review experience (Preferred)

Licenses and Certifications

• Lead Auditor Qualification (Preferred)

Computer Skills

• Proficient in MS Office and other computer programs

SGS is an Equal Opportunity Employer, and as such we recruit, hire, train, and promote persons in all job classifications without regard to race, color, religion, sex, national origin, disability, age, marital status, sexual orientation, gender identity or expression, genetics, status as a protected veteran, or any other characteristics protected by law.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily with or without reasonable accommodations. The requirements listed above are representative of the knowledge, skills, and/or abilities required.

This job description should not be construed as an exhaustive statement of duties, responsibilities or requirements, but a general description of the job. Nothing contained herein restricts the company’s rights to assign or reassign duties and responsibilities to this job at any time.

If you are applying for a position within the United States and you have difficulty completing the on-line employment application because of a disability, please call 201-508-3149 for assistance and leave a message. You will receive a call back.  Please note, this phone number is not for general employment information, but is only for individuals who are experiencing difficulty applying for a position due to a disability

All your information will be kept confidential according to EEO guidelines.