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

Overview

The Associate Director for In Vitro Diagnostic Regulation (IVDR) Writing Services will leverage regulatory writing expertise and leadership skills to manage and write regulatory-compliant performance evaluation reports for healthcare companies.

In Short

• Lead multiple performance evaluation report writing projects.
• Provide scientific oversight on assigned projects.
• Collaborate with the Resourcing team for project assignments.
• Review regulatory documents and responses to authorities.
• Conduct systematic literature reviews for IVDs.
• Coach project activities to ensure regulatory compliance.
• Ensure documents meet internal and external guidelines.
• Contribute to company process development and improvement.
• Manage teams effectively with demonstrated leadership.
• Utilize strong command of medical and laboratory terminology.

Requirements

• Experience writing CERs and/or PERs compliant with MEDDEV and EU regulations.
• Effective written and verbal communication skills.
• Strong command of medical and laboratory terminology.
• Ability to adapt to shifting priorities.
• Proven leadership in managing teams.
• Highly skilled in document management software.
• Training in science, engineering, or medical fields.
• Deep understanding of research design and methodology.

Benefits

• Work remotely from anywhere.
• Engage with top industry clients.
• Empower healthcare solutions.
• Participate in a collaborative team environment.
• Access to professional development opportunities.