Senior IVDR Writing Leader for PER/CER (Remote)

Criterion Edge; Remote; MYR 150,000 - 200,000; Full time

Job summary

A leading healthcare solutions firm is seeking an Associate Director for In Vitro Diagnostic Writing Services. This remote role involves management oversight and regulatory writing expertise for EU IVDR submissions. Ideal candidates will have prior experience writing regulatory documents and leading teams, alongside a strong command of medical terminology. The position includes responsibilities like project oversight, document reviews, and collaboration with teams to enhance quality standards. Interested applicants should submit their resume and cover letter.

Qualifications

• Previous experience writing CERs and/or PERs per MEDDEV 2.7/1 rev 4, EU MDR, or EU IVDR.
• Demonstrated ability to identify and adapt to shifting priorities.
• Scientific/research background required, with understanding of research design.

Responsibilities

• Provide consistent expert oversight on all projects.
• Collaborate with teams to assign writing resources.
• Review and provide feedback on regulatory documents.
• Oversee the literature review process for IVDs.

Skills

Expert scientific oversight

Collaboration with teams

Management of teams

Strong command of medical terminology

Effective communication skills

Education

Degree in science, engineering, or medical field

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

EndNote

Job description

A leading healthcare solutions firm is seeking an Associate Director for In Vitro Diagnostic Writing Services. This remote role involves management oversight and regulatory writing expertise for EU IVDR submissions. Ideal candidates will have prior experience writing regulatory documents and leading teams, alongside a strong command of medical terminology. The position includes responsibilities like project oversight, document reviews, and collaboration with teams to enhance quality standards. Interested applicants should submit their resume and cover letter.