Medical Writer

HelloHope you are doing well. This is Jahera and I'm a recruiter at Intellectt, Inc. Please find the job description and reach out to me with an updated copy of your resume. You can send it to jahera@intellectt. com or call me at +1(732)-276-1791Role: Medical Writer IILocation: Abbott Park, IL (100% Onsite)Duration: 12 monthsShift: Monday-Friday, 8 AM - 5 PMJob OverviewThis role supports the transfusion medicine division focused on regulatory writing for blood screening diagnostics within the in vitro diagnostics (IVD) space.

This is a specialized regulatory writing role requiring in-depth knowledge of FDA (PMA, ABLA, 510(k)) and EU IVDR submissions. Key ResponsibilitiesAuthor, proofread, and edit technical documents for regulatory submissions. Collaborate with cross-functional teams (e. g. , R&D, clinical affairs) for regulatory document preparation. Ensure compliance with FDA and European Union (EU) regulatory standards for IVD submissions. Required QualificationsExperience: Minimum 5 years in regulatory documentation, particularly for FDA and EU submissions (IVD, medical devices, or pharmaceuticals). Education: Degree in journalism, English, life sciences, or related field. Skills: Strong technical writing and proofreading abilities. Proven experience with FDA and EU regulatory requirements.

Industry Knowledge: Background in blood screening products beneficial but not required. Preferred SkillsExpertise in regulatory writing for IVD or medical devices. Ability to translate complex information into clear, compliant narratives.