Remote IVD Regulatory Review Specialist

Jobgether; United States; Remote; USD 110,000 - 160,000; Full time

Benefits offered by this job

Remote work within the United States

Job summary

Jobgether is seeking an IVDR Product Reviewer based in the United States to assess technical documentation for CE marking of IVD and related medical devices. You will analyze scientific evidence, evaluate conformity to standards, and prepare comprehensive reports for regulatory decisions.

Work with clinical experts, performance evaluators, and project managers to ensure rigorous, timely assessments. Travel may be required, and remote work within the United States is supported.

Qualifications

• Education: university or technical college degree in a relevant discipline such as medicine, pharmacy, engineering, or other scientific field.
• Professional Experience: at least four years in healthcare products or related activities (manufacturing, auditing, research, etc.).
• Regulatory knowledge: CE marking and conformity assessment in EU regulatory framework.

Responsibilities

• Conduct CE type examinations and design dossier or product assessments for IVD and other devices.
• Independently review or collaborate to assess documentation for conformity with regulations and standards.
• Evaluate evidence to determine safety, performance, quality, and intended-use compliance.
• Prepare evidence-based assessment reports to support or reject CE marking.
• Coordinate with multidisciplinary teams to meet deadlines and maintain consistency.
• Consolidate findings and communicate conclusions clearly across review activities.
• Monitor evolving regulatory requirements and share relevant updates with colleagues.
• Participate in workshops, standardization activities, and training sessions.
• Deliver training, technical presentations, and educational activities.
• Maintain impartiality, confidentiality, and objectivity in evaluations.
• Organize and prioritize multiple assessments with reliable records.
• Perform additional duties to support quality and compliance.

Skills

Regulatory knowledge

Technical assessment

Scientific/analytical ability

Technical writing

Verbal communication

Organization/time management

Collaboration

Professional integrity

Regulatory monitoring

Adaptability

Remote/work readiness

Travel readiness

Education

University/technical degree in medicine, pharmacy, engineering or related science

Tools

Job description

Jobgether is seeking an IVDR Product Reviewer based in the United States to assess technical documentation for CE marking of IVD and related medical devices. You will analyze scientific evidence, evaluate conformity to standards, and prepare comprehensive reports for regulatory decisions.

Work with clinical experts, performance evaluators, and project managers to ensure rigorous, timely assessments. Travel may be required, and remote work within the United States is supported.