Medical Writer Medical Devices
Criterion Edge is seeking a remote Medical Writer to join our best-in-class writing team and help elevate our customer-focused writing services.
Employment Type and Location: Remote, Part-Time or Full-Time Employee
Job Overview
As a Medical Writer, you will work closely with other writers, project managers, and support specialists to develop regulatory and clinical documentation for medical device clients. Deliverables may include clinical evaluation plans and reports, systematic literature review reports, post-market surveillance and post-market clinical follow-up documents, periodic safety update reports, summaries of safety and clinical performance, clinical investigation documents, and regulatory submission content.
The ideal candidate is a medical writing qualified seeking to build on their experience in medical device clinical, regulatory, or scientific writing. The successful candidate will apply scientific judgement, medical device regulatory knowledge, and strong written and oral communication skills to develop evidence-based documents that meet client requirements and applicable regulatory expectations.
Roles and Responsibilities
As a member of the project writing team, you will be responsible for producing assigned documents and reports to a high professional standard. Specific responsibilities include:

- Write and revise medical device regulatory and clinical documents, including clinical evaluation plans and reports, systematic literature review reports, post-market surveillance plans and reports, post-market clinical follow-up plans and evaluation reports, periodic safety update reports, summaries of safety and clinical performance, clinical investigation documents, and regulatory submission content.
- Evaluate clinical, scientific, post-market, risk management, usability, and device performance information and integrate relevant evidence into regulatory documents.
- Conduct or support systematic literature reviews, including protocol development, literature screening, data extraction, critical appraisal, evidence synthesis, and documentation of reproducible search and review methods.
- Assess the relevance, quality, applicability, and limitations of clinical evidence and ensure that conclusions are appropriately supported by the available data.
- Maintain consistency among clinical evaluation, risk management, post-market surveillance, post-market clinical follow-up, labeling, and other related technical documentation.
- Support responses to client, notified body, competent authority, and regulatory agency questions or deficiencies.
- Identify gaps in clinical evidence, source documentation, regulatory alignment,



or document traceability and communicate those gaps to the project team.
- Organize and manage assigned project workloads and tasks, identify project needs, and adhere to established timelines.
- Understand client expectations and work collaboratively to meet those expectations through effective teamwork, adherence to deadlines, problem-solving, and application of scientific knowledge.
- Collaborate effectively with writers, project managers, scientific experts, quality control reviewers, and other members of the project writing team.
- Work with a Criterion Edge Project Manager to document assigned tasks, estimated hours, and due dates in the project plan and provide weekly progress updates.
- Maintain current knowledge of medical device writing best practices and applicable laws, regulations, standards, and evolving regulatory guidance, including Regulation (EU) 2017/745, UK Medical Devices Regulation, as amended, applicable U.S. FDA requirements and guidance, and relevant international standards.
- Participate in quality control reviews and verify document accuracy in accordance with established internal quality control processes.
- Provide clear, constructive written and verbal feedback to junior staff, peers, and managers, as appropriate.
- Serve as a project mentor, when requested, to assist in the training and development of junior staff on your project team(s).
- Establish and maintain effective, professional working relationships with co-workers, managers, and clients.
- Demonstrate initiative and sound judgement when addressing unfamiliar project requirements, document types, or technical challenges.
- Seek clarification and guidance from Project Lead and/or Project Manager when project requirements, expectations, or next steps are unclear.

Qualifications and Skills

- Two or more years of direct experience developing regulatory, clinical, or scientific documentation for medical devices.
- Minimum of a bachelor's degree in a life science or related discipline.
- Advanced word-processing skills and document-management skills, including proficiency with Microsoft Word, Excel, Microsoft Office, Adobe Acrobat, and collaborative document-sharing platforms such as SharePoint.
- Ability to learn and adapt to new information technology systems, AI-assisted workflows, project management platforms, and document-development tools.




- Working knowledge of medical device regulatory requirements and guidance, including the EU MDR, UK MDR 2002 (as amended), applicable U.S. FDA requirements, MDCG guidance, MEDDEV guidance, and relevant international standards.
- Experience developing or contributing to clinical evaluation, post-market surveillance, post-market clinical follow-up, systematic literature review, or medical device regulatory submission documents.
- Familiarity with medical device technical documentation and the relationships among clinical evaluation, risk management, post-market surveillance, labeling, usability, and device performance documentation.
- Ability to interpret clinical and scientific evidence in relation to a device's intended purpose, indications for use, target population, clinical benefits, risks, and state of the art.
- Knowledge of and experience with systematic literature review methodology and best practices, including search protocol development, Level 1 and Level 2 literature screening, data extraction, critical appraisal, evidence weighting, evidence synthesis, and documentation of reproducible literature review methods.
- Native or professional-level English fluency, with excellent oral (including presentation) and written communication, including grammatical/technical writing skills.
- Ability to interact confidently with external stakeholders and communicate clearly and professionally with individuals at all organizational levels.
- Ability to work independently, manage competing priorities, and achieve assigned project goals with minimal supervision.
- Demonstrated ability to produce high-quality written deliverables in accordance with client requirements, project specifications, and agreed-upon timelines.
- Excellent attention to detail, accuracy, consistency, and document quality.
- Ability to contribute, collaborate, share responsibilities, and support team members in achieving project goals.
- Demonstrated scientific rigor and a strong understanding of the scientific process as applied to the development of regulatory and clinical documents.

About Criterion Edge:
At Criterion Edge, we're committed to empowering companies to deliver better healthcare solutions. By leveraging best-in-class writing processes, technology, and experience, our expert team of writers and project managers support healthcare companies to achieve their global regulatory goals with superior quality, speed, and budget control.
Be on the leading edge by applying your regulatory and/or scientific writing expertise and leadership skills to the development, management and writing of regulatory-compliant projects with top industry clients.

📌 Medical Writer - Medical Devices (Hyderabad)
🏢 Criterion Edge
📍 Hyderabad