Product Assessor - Medical Devices (Active & Software) - Remote

Overview

We are currently seeking a highly skilled and detail-oriented Product Assessor to join our team. In this position, you will be responsible for conducting technical file reviews against the European Medical Device Directive and Medical Device Regulation for Class I/IIa/IIb and/or Class III medical devices.

In Short

• Ensure that reviews are technically sound and in compliance with all applicable requirements
• Support in training and qualification of colleague and create training materials
• Ensure adherence to SGS policies, procedures, and processes
• Communication with team members and client with regards to the product assessment or other activities performed
• Minimize risks associated with medical device certification
• Ensure regulatory compliance of product technical file assessment under applicable EU Medical Devices Directives and /or Regulations and those for UKCA
• Conduct product assessments (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 to be able to assess product technical documentation on an ongoing basis.
• Project manage assessments as appropriate, to maximize efficiencies, enhance client satisfaction, and ensure compliance with requirements
• To assist with queries raised from product assessments

Requirements

• Bachelor’s degree in engineering, medicine, pharmacy, information technology, or other relevant studies
• 4+ years professional experience in the field of healthcare products or related activities
• Active Medical Devices knowledge
• Thorough knowledge and understanding of related standards: EN 60601, EN 62304, EN 62366, etc.
• Understanding of the clinical application of the technology
• Experiences in cybersecurity and AI

Benefits

• Medical, dental and vision insurance, company-paid life, accident and long-term disability insurance
• Competitive pay ($134,000-$180,000 USD based on experience)
• Matching 401(k) with immediate vesting upon enrollment
• Online training courses, virtual and classroom development experiences
• Paid-time vacation, sick, company holidays