Regulatory Medical Writer Jobs

Internal Title: In vitro Diagnostic Regulation Technical Writer

Duration: 3 Month Contract

Location: Onsite in IL or Remote

Duties / Expectations of Role

• Excellent communication skills
• Works independently with some supervision.
• Excellent technical writing skills
• Expected to meet quality standards for accuracy and completeness of documentation.
• Utilizes submission templates (if available) and format/style guidelines provided.
• Obtain relevant product data and information
• Converts relevant product data and information into a form that is clear, complete, accurate, and meets submission requirements.
• Understand source information
• Working knowledge of in vitro diagnostic regulation (IVDR)
• Ability to work in a fast-paced environment with effective use of prioritization, organization, and time management skills.
• Provide critical thinking and analysis of conclusions drawn from clinical evidence to ensure the intent of the regulation being met.
• Problem-solving skills
• Ability to review scientific literature for applicability for inclusion in the product technical file documentation.

Mandatory Requirements

• Minimum of 3-5 years of experience in medical device regulatory affairs, US or international.
• Bachelor’s degree (BS/BA) in a scientific field
• Experience writing IVDR technical file documents
• Demonstrated organizational skills necessary to support cross-functional product submission preparation.