Associate Director, In Vitro Diagnostic Regulation (IVDR) Writing Services

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

Job Type: Full-Time, Remote

Experience Level: Experienced

Overview

At Criterion Edge, we’re committed to empowering companies to deliver better healthcare solutions. By leveraging best‑in‑class writing processes, technology, and expertise, we empower healthcare companies to achieve their global regulatory goals with superior quality, speed, and budget control. Be on the leading edge by applying your regulatory writing expertise and leadership skills to the development, management and writing of regulatory‑compliant performance evaluation reports (PER) projects with top industry clients.

Criterion Edge (CE) is seeking a remote candidate for the role of Associate Director, In Vitro Diagnostic Writing Services. The position is responsible for providing management oversight and regulatory/scientific writing expertise to support and lead multiple PER writing projects that support EU IVDR submission requirements for the client’s portfolio of IVD products. Previous PER or CER writing experience and management of medical regulatory writers is required for this role.

Responsibilities

• Provide consistent, expert scientific oversight on all assigned projects.
• Collaborate with the Resourcing team to assign appropriate writing resources to each project.
• Oversee initial scoping of new projects and attend project kickoff meetings.
• Review regulatory documents and responses to regulatory authorities, specifically working on Performance Evaluation Reports (PERs).
• Conduct high‑level review and provide feedback to project team.
• Review/oversee the systematic literature review process (e.g. screen articles against inclusion/exclusion criteria, extract data from included studies, interpret study results, synthesize literature, and prepare summaries into formal reports) for IVDs.
• Provide input into company process development and improvement.
• Ensure documents are produced in accordance with procedures, internal and external guidelines, and electronic templates.
• Coach all project‑related activities to ensure alignment with applicable regulatory requirements and Criterion Edge quality standards.

Required Experience & Qualifications

• Previous experience writing CERs and/or PERs and related documents in accordance with MEDDEV 2.7/1 rev 4 and/or EU MDR and/or EU IVDR.
• Effective written, verbal, and presentation skills in technical/laboratory diagnostics.
• Strong command of medical and laboratory terminology.
• Demonstrated ability to identify and adapt to shifting priorities and competing demands.
• Proven leadership in the management of teams.
• Highly skilled in document development and management using Word, Excel, PowerPoint and EndNote.
• Training and degree in science, engineering, or medical field(s). Scientific/research background required, with a deep understanding of research design, methodology, and statistics.

How to Apply

If interested, please submit a resume/CV and a cover letter to [e-mail].