Engineering – Prin Technical Writer
Listed on 2026-09-28
-
Business
Regulatory Compliance Specialist
Pay 50-60/h depending on experience
HM's Top Needs:Medical Devices experience (minimum 6 years) creating artwork files using Adobe Illustrator and Indesign in technical communication/technical writing/ labeling development/content generation
SME knowledge of Instructions for use (IFU) and other labeling content requirements
Labeling Standards and Regulations expertise
Education Required:
Master's in regulatory or any engineering field.
Years' Experience
Required:
minimum 6years
The Principal Technical Writer leads the development and lifecycle management of customer-facing medical devices labeling content and artwork for neurovascular medical devices, including Instructions for Use (IFUs), user guides, electronic labeling, and preprinted packaging materials. This role translates complex technical and regulatory information into clear, accurate, user-focused content for healthcare professionals, clinicians, and patients. Working across new product development and sustaining initiatives, the position ensures labeling deliverables meet global regulatory requirements, design control expectations, quality standards, and business objectives.
Key Responsibilities- Labeling Development: Lead the end-to-end creation, revision, and optimization of IFUs, user guides, electronic labeling, and preprinted packaging artwork from concept through final release using Adobe Indesign, Illustrator, content management and other tools and technology.
- Content Strategy: Define documentation and artwork requirements, gather cross-functional inputs, and translate complex technical information into accurate, accessible content for technical and nontechnical users.
- Regulatory and Quality Compliance: Ensure labeling conforms to applicable global regulations and standards, including but not limited to FDA, EU MDR, IMDRF, UDI, IEC
60601, ISO
20417, ISO
15223, as well as internal quality management system requirements. - Cross-Functional Leadership: Partner with R&D, Regulatory Affairs, Quality, Marketing, Medical Safety, Clinical, and other stakeholders to align content, resolve issues, and deliver labeling milestones on schedule.
- Risk and Change Management: Assess compliance gaps and implementation risks, lead Change Orders and design control deliverables, and maintain substantiation, traceability, review, and verification documentation.
- Lifecycle Management: Support product launches, sustaining activities, and legacy document maintenance while driving standardization, version control, and compliant implementation across the labeling lifecycle.
- Regulatory Intelligence: Monitor evolving regulatory requirements and provide timely, practical guidance to project teams and leadership.
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