Regulatory Medical Writer In Vitro Diagnostics (IVD)
Employment Type: Full-Time or Part-Time Employee
Location: Remote

About Criterion Edge
Criterion Edge is a global scientific and regulatory consulting company specializing in regulatory writing, medical writing, evidence generation, and literature review services for medical device and in vitro diagnostic (IVD) manufacturers.
Our team partners with clients worldwide to develop high-quality, regulatory-compliant documentation supporting FDA, EU IVDR, UKCA, Health Canada, TGA, and other international regulatory submissions.
At Criterion Edge, we believe scientific excellence begins with exceptional people. We foster a collaborative, flexible, and intellectually stimulating work environment where writers are encouraged to expand their scientific expertise while working on innovative diagnostic technologies that improve patient care worldwide.
Joining Criterion Edge provides the opportunity to work alongside industry-leading regulatory professionals, contribute to high-impact global regulatory submissions, and play a meaningful role in helping clients successfully navigate the increasingly complex regulatory landscape for in vitro diagnostic medical devices.

Position Summary
Criterion Edge is seeking an experienced Regulatory Medical Writer In Vitro Diagnostics (IVD) to join our growing team of regulatory and scientific experts. This position is ideally suited for an individual who enjoys translating complex scientific and clinical information into clear, well-organized regulatory documentation that supports global market access for innovative diagnostic technologies.

As a Senior Regulatory Medical Writer, you will serve as a scientific and regulatory expert responsible for authoring, reviewing, and managing documentation supporting the development and commercialization of in vitro diagnostic devices. Working closely with Regulatory Affairs, Clinical Affairs, Biostatistics, Quality Assurance, Research and Development, and client subject matter experts, you will develop regulatory-compliant documentation for submissions to the U.S. Food and Drug Administration (FDA), European Union Notified Bodies, and other international regulatory agencies.

The successful candidate will possess extensive experience preparing documentation supporting FDA 510(k), De Novo, PMA, CLIA Waiver, and Q-Submission programs, as well as EU IVDR Technical Documentation, including Performance Evaluation Reports,



Scientific Validity Reports, and other documentation required under Regulation (EU) 2017/746.

Essential Responsibilities
In this role, you will be responsible for developing a broad range of scientific and regulatory documents supporting all phases of the regulatory lifecycle for in vitro diagnostic devices. You will author, edit, and critically review Technical Documentation, Scientific Validity Reports, Performance Evaluation Plans, Performance Evaluation Reports, analytical and clinical performance reports, clinical evidence reports, State of the Art literature reviews, risk-benefit analyses, Instructions for Use, labelling documentation, and responses to regulatory authority questions.
You will work collaboratively with multidisciplinary project teams to interpret complex scientific, analytical, and clinical data and transform those data into explicit, accurate, and scientifically defensible regulatory submissions. This includes integrating information from multiple technical disciplines while ensuring consistency across all project documentation.
A significant component of the role involves conducting comprehensive literature reviews and evidence syntheses to support regulatory submissions. The successful candidate will have experience designing and conducting systematic literature reviews, performing literature screening and data extraction, critically appraising published evidence, and developing regulatory-grade evidence summaries supporting scientific validity, analytical performance, clinical performance, and intended use claims under IVDR and FDA requirements.
You will contribute throughout the regulatory submission process by preparing documentation supporting FDA 510(k), CLIA Waiver, De Novo, PMA, and Q-Submission programs, as well as EU IVDR conformity assessment submissions. Additional responsibilities include preparing responses to FDA requests for additional information, addressing Notified Body review comments, and supporting post-market documentation, design changes, and international regulatory submissions.
As a member of our Scientific Writing Team,



you will collaborate closely with project managers to estimate project timelines, manage multiple writing assignments simultaneously, identify potential project risks, and ensure all deliverables are completed according to project schedules. You will also mentor junior writers, participate in document quality control reviews, contribute to the continuous improvement of internal templates and standard operating procedures, and support the ongoing development of Criterion Edge's regulatory writing capabilities.

Required Qualifications
The ideal candidate will possess a bachelor's degree in biology, molecular biology, biomedical sciences, medical laboratory science, biotechnology, chemistry, pathology, immunology, or another relevant life science discipline. An advanced degree (MS or PhD) is preferred.
Candidates should have a minimum of one to three years of regulatory medical writing experience supporting medical devices or, preferably, in vitro diagnostic devices. Previous experience within a regulatory consulting organization or contract research organization is highly desirable.
Candidates should demonstrate experience supporting a wide range of diagnostic technologies, including molecular diagnostics, PCR, quantitative PCR, digital PCR, next-generation sequencing, immunoassays, ELISA, lateral flow immunoassays, clinical chemistry, hematology, point-of-care diagnostics, companion diagnostics, and emerging digital pathology or artificial intelligence-enabled diagnostic systems.
Exceptional scientific writing and editing skills are essential. The successful candidate will have demonstrated expertise in preparing clear, concise, and scientifically rigorous regulatory documentation, interpreting complex scientific literature, and communicating effectively with multidisciplinary scientific teams and external clients.
Experience with Microsoft Office, Adobe Acrobat, and literature management software such as EndNote or Zotero is expected. Familiarity with systematic literature review platforms such as DistillerSR is also considered an asset.
Professional certifications such as Regulatory Affairs Certification (RAC) or certification through the American Medical Writers Association (AMWA) are desirable but not required. Experience interacting directly with FDA reviewers, European Notified Bodies, or other international regulatory agencies will be considered a significant advantage.

📌 IVD Medical Writer (Hyderabad)
🏢 Criterion Edge
📍 Hyderabad