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

Criterion Edge

5d • Remote

About The Position

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. Please note that previous PER or CER writing experience and management of medical regulatory writers is required for this role.

Requirements

• 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

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 kick-off 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: No Education Listed
• Number of Employees: 11-50 employees