Medical Writing Specialist

Integra LifeSciences

Medical Writing Specialist developing regulatory documentation for medical communications. Collaborating closely with cross-functional teams and ensuring compliance with EU and FDA standards.

Posted 4/15/2026full-time🇺🇸 United StatesJuniorMid-Level💰 $62,000 - $85,000 per yearWebsite

About the role

Key responsibilities & impact

Edit, review, and format medical writing deliverables to ensure scientific accuracy, clarity, consistency, and regulatory compliance
Support Clinical Evaluation Reports (CERs), PMCF plans, PMCF evaluation reports, clinical summaries, and related regulatory documentation in alignment with EU MDR requirements
Maintain project trackers, timelines, deliverables, dashboards, and workflow tools to support department operations
Coordinate with cross-functional stakeholders to support post-market clinical follow-up activities and document updates
Manage reference libraries and literature management tools; coordinate issue resolution with IT and software vendors as needed
Ensure secure storage, retrieval, version control, and inspection readiness of medical communications documentation
Support vendor coordination to ensure timely, high-quality document deliverables
Prepare meeting agendas, track action items, and distribute meeting notes and resources
Ensure departmental procedures and documentation comply with applicable clinical, regulatory, and quality requirements
Update and track global standard operating procedures and support Change Review Board preparation activities
Monitor project risks and stakeholder needs to ensure alignment with departmental objectives

Requirements

What you’ll need

Master’s degree or PhD in scientific discipline is preferred
Bachelor’s degree in scientific or healthcare discipline may be considered with six years of experience
Minimum 2 years of writing experience in the medical device or pharmaceutical industry
Experience with systematic literature reviews, writing literature protocols and literature reports
Ability to produce clinical evaluation plans/reports with minimal oversight
Strong technical writing skills
Bibliographic research and editorial skills
Ability to interpret and disseminate relevant product information
Proficiency in MS Office applications
Proficiency in EndNote or Reference Manager
Basic understanding of regulatory compliance for medical devices
Maintains general knowledge of industry, regulatory, marketing, linguistic, and publication standards
Strong organizational skills, attention to detail and proofreading skills
Working knowledge of EU MDR clinical evaluation and post-market clinical follow-up requirements

Benefits

Comp & perks

medical
dental
vision
life insurance
short- and long-term disability
business accident insurance
group legal insurance
savings plan (401(k))

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

medical writingclinical evaluation reportssystematic literature reviewstechnical writingbibliographic researchregulatory complianceclinical evaluation planspost-market clinical follow-upattention to detailproofreading

Soft Skills

organizational skillscommunicationcoordinationstakeholder managementproblem-solvingtime managementteam collaborationaction item trackingagenda preparationissue resolution