The Technical Writer / Proofreader will be responsible for creating, editing, proofreading, maintaining, and controlling regulatory-compliant product labeling and technical documentation for medical device and in vitro diagnostic (IVD) products. This role ensures documentation is accurate, clear, consistent, and compliant with applicable regulatory requirements, Quality Management System (QMS) procedures, and corporate standards.
The position will collaborate closely with Regulatory Affairs, Quality, R&D, Marketing, Product Management, Manufacturing, and Operations teams throughout the product lifecycle.
Create, edit, proofread, and maintain technical and regulatory documentation for medical device and IVD products.
Develop and maintain product labeling, Instructions for Use (IFUs), user manuals, product inserts, packaging content, and other customer-facing documentation.
Review documentation for grammar, spelling, clarity, consistency, formatting, technical accuracy, and compliance.
Ensure product labeling and technical documentation comply with applicable regulatory requirements and internal QMS procedures.
Partner with Regulatory Affairs and Quality teams to incorporate regulatory and compliance requirements into documentation.
Work with R&D, Engineering, Product Management, Marketing, Manufacturing, and Operations to gather and validate technical information.
Manage document revisions, version control, change control, and document lifecycle activities.
Review and implement updates resulting from product changes, regulatory requirements, CAPAs, complaints, risk assessments, and other quality activities.
Ensure consistent terminology, formatting, branding, and messaging across product documentation.
Support documentation reviews and approvals through established document-control processes.
Identify documentation inconsistencies, errors, and gaps and coordinate corrections with appropriate stakeholders.
Maintain documentation according to applicable QMS, document-control, and records-management procedures.
Support audits and regulatory inspections by ensuring documentation is complete, accurate, current, and traceable.
Bachelor's degree in Technical Writing, Communications, English, Life Sciences, Engineering, or a related field preferred.
3–5+ years of experience in technical writing, regulatory documentation, labeling, or a related documentation role.
Experience working in the medical device, IVD, diagnostics, pharmaceutical, or other highly regulated industry.
Hands-on experience creating, editing, and proofreading technical and customer-facing documentation.
Experience with medical device labeling, IFUs, product manuals, packaging, or regulatory documentation strongly preferred.
Working knowledge of FDA regulations, 21 CFR, ISO 13485, EU MDR/IVDR, or similar regulatory requirements.
Experience working within a Quality Management System (QMS) and controlled-document environment.
Experience with document revision, change control, version control, and approval workflows.
Strong attention to detail and excellent written and verbal communication skills.
Ability to interpret technical information and translate complex concepts into clear, concise documentation.
Strong collaboration skills with cross-functional teams including Regulatory Affairs, Quality, R&D, Engineering, Marketing, and Manufacturing.
Proficiency with Microsoft Word, Excel, PowerPoint, Adobe Acrobat, and document-management systems.
Experience with medical device or IVD product labeling and Instructions for Use (IFUs).
Experience supporting FDA submissions, regulatory changes, or product lifecycle documentation.
Familiarity with UDI, symbols, warnings/precautions, claims, and labeling requirements.
Experience with electronic document management systems (EDMS), PLM, or QMS platforms.
Experience working with global regulatory requirements and multilingual labeling.
Experience supporting internal, customer, or regulatory audits.
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