Medical Device Writer

Criterion Edge

. Produce regulatory and scientific reports, plans, and other written deliverables for medical device, pharma/biotech, and in vitro device clients .

Posted 11/11/2026full-timeRemote • IndiaJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory and scientific writing for medical devices and pharmaceuticals, with a strong focus on producing high-quality deliverables that meet client expectations and adhere to timelines. Proficient in systematic literature review methodologies and maintaining effective communication with stakeholders.

Highest-signal resume keywords

Regulatory Writing ExperienceSystematic Literature Review MethodologyAdvanced Word Processing SkillsHigh Level of English FluencyAttention to Detail

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory WritingScientific WritingSystematic Literature ReviewData ExtractionTechnical WritingDocument Quality ControlProject ManagementData AppraisalScientific RigorDocument Revision

Soft Skills

Team CollaborationEffective CommunicationProblem-SolvingMentoringInitiative

Tools & Technologies

Microsoft OfficeAdobe AcrobatAsanaSharePointCollaborative Document Sharing Platforms

Industry Keywords

Medical DevicePharmaceuticalIn Vitro DeviceLife SciencesRegulatory Guidelines

About the role

Key responsibilities & impact

Produce regulatory and scientific reports, plans, and other written deliverables for medical device, pharma/biotech, and in vitro device clients
Write documents or document sections on assigned projects
Organize project workload and tasks, identify project needs, and adhere to timelines
Understand and meet client expectations through teamwork, deadlines, problem-solving, and scientific knowledge
Collaborate with the project writing team
Document assigned tasks, time estimates, and due dates in Asana project plans with the Project Manager
Provide weekly progress updates
Ensure document data are clear, complete, accurate, and concise
Ensure statements and conclusions are integrated, balanced, data-supported, and consistent across related documents
Address expert and scientific review comments and revise content based on internal and external feedback
Stay current with medical writing best practices and relevant regulatory knowledge
Identify project risks and bring them to the project team for resolution
Participate in quality control checks following internal QC processes
Provide written and verbal feedback to junior staff and managers
Mentor junior staff when requested
Maintain effective professional relationships with co-workers, managers, and clients
Exercise initiative and sound judgment when handling unfamiliar project requirements or document challenges
Seek clarification from the Project Lead or Project Management before proceeding

Requirements

What you’ll need

2+ years of direct writing experience in pharmaceutical, medical device, in vitro device, or related academic fields
Minimum of a BSc in a life sciences or related discipline / related field
Advanced word processing skills, including Microsoft Office (including Word), Adobe Acrobat, Excel, and collaborative document sharing platforms such as SharePoint
Ability to learn and adapt to various IT systems
Familiarity with all current and applicable guidelines and regulations governing the assigned project
Knowledge of and experience with systematic literature review (SLR) methodology and best practices, including Level 1 and Level 2 literature screening, data extraction, and weighting and appraisal of data sets
High level of English fluency or native English speaker
Excellent oral, presentation, written, grammatical, and technical writing skills
Ability to interact confidently with external stakeholders and communicate effectively and clearly
Ability to work independently with minimal supervision
Ability to produce high-quality written deliverables according to customer and project requirements and agreed timelines
Excellent attention to detail and accuracy
Demonstrated scientific rigor and understanding of the scientific process in written documents

Benefits

Comp & perks

Remote work arrangement
Opportunity to work with a best-in-class writing team
Collaboration with writers, project managers, and support specialists
Training and development opportunities through project mentorship