Remote IVDR CE Conformity Reviewer

Automatic Data Processing, Inc.; United States; À distance; USD 90 000 - 120 000; Plein temps

Résumé du poste

Automatic Data Processing, Inc. is seeking an IVDR Product Reviewer to perform CE marking evaluations for medical devices and IVDs, ensuring compliance with European regulations and standards.

The role involves independent and team reviews, producing reports that support or reject CE certification. This full-time remote position requires extensive regulatory knowledge, cross-functional collaboration, and the ability to deliver timely, quality assessments while maintaining confidentiality and

Qualifications

• University degree in medicine, pharmacy, engineering or related sciences.
• 4 years of professional experience in healthcare products or related activities.
• 2 years in design, manufacture, testing, or use of the device or technology to be assessed.

Responsabilités

• Conduct CE type and CE design dossier/product review evaluations in the framework of the applicable European Regulations (CE) for different device classes and for a wide range of medical devices and IVDs depending on area of expertise.
• Coordinate with other product reviewers/evaluators, clinical experts, performance evaluators, process experts, technical experts, and the certification project managers to meet review timelines, provide quality reports, and ensure information consistency.
• Participate in standardization, technical, and regulatory workshops or speaking events.
• Ensure active regulatory monitoring and communication within the team of new requirements identified in your areas of medical device expertise.
• Pedagogical responsibility and the animation of training sessions or technical days.
• Perform other duties and responsibilities as required or requested.

Connaissances

Detail-oriented

Meet deadlines

Confidentiality

Reliability

Organizational skills

Prioritization

Teamwork

Critical reasoning

Verbal communication

Written communication

Record keeping

Formation

Bachelor’s degree or equivalent

Description du poste

Automatic Data Processing, Inc. is seeking an IVDR Product Reviewer to perform CE marking evaluations for medical devices and IVDs, ensuring compliance with European regulations and standards.

The role involves independent and team reviews, producing reports that support or reject CE certification. This full-time remote position requires extensive regulatory knowledge, cross-functional collaboration, and the ability to deliver timely, quality assessments while maintaining confidentiality and