Associate Director, IVDR Writing Services

Job Summary

A company is looking for an Associate Director, In Vitro Diagnostic Regulation (IVDR) Writing Services.

Key Responsibilities

• Provide expert scientific oversight on assigned projects
• Collaborate with the Resourcing team to assign writing resources and oversee project scoping
• Review regulatory documents, manage the literature review process, and ensure compliance with guidelines

Required Qualifications

• Previous experience writing CERs and/or PERs in accordance with relevant EU regulations
• Strong command of medical and laboratory terminology
• Proven leadership in managing teams
• Training and degree in science, engineering, or medical fields
• Demonstrated understanding of research design, methodology, and statistics