MadCap Flare Technical Writer
The Planet Group, Boston, MA, United States
MadCap Flare Technical Writer – (Contract‑To‑Hire) – Hybrid – MA
Global Medical Equipment Manufacturer seeks a Technical Writer to author, revise and maintain end user documentation for medical devices in compliance with regulatory and quality system requirements. This person must have 3+ years’ experience working in an FDA/ISO regulated environment and extensive MadCap Flare expertise for structured and reusable content development. This individual will operate independent while also liaising cross‑functionally with other departments to ensure documentation accuracy, compliance and consistency across all product lines.
This requires a W2‑paid employee local to the Boston area within a commutable distance and ability to be in office 3 days weekly. Ideal candidate will be willing to start as a consultant and then move into permanent employment after 6 months.
$35 - $50 W2 hourly pay based on individual and expertise.
A 6‑month contract with the potential to convert to a permanent position.
Base Compensation ranges from $80,000 to $98,000 based on individual and expertise.
Urgent role with a desired start in March 2026.
Requirements
Bachelor’s Degree in English or Technical Writing.
3+ years’ experience as technical writer in Life Sciences Industries, ideally Medical Devices or In Vitro.
Located within the greater Boston area and able to commute onsite 3 days per week.
Advanced expertise in MadCap Flare to include project architecture, conditional text, variables, and content reuse strategy.
Expertise in Quality Management Systems (QMS).
Familiarity with global labeling requirements to include FDA, EU MDR, IVDR, Health Canada, etc.
Preferred Expertise
Experience in Adobe Acrobat and FrameMaker, and other graphics tools.
Knowledge of Smartsheet is highly desired.
Responsibilities
Authoring, revising, and maintaining end‑user documentation in compliance with regulatory and quality system requirements.
Developing, editing, and maintaining Instructions for Use (IFUs), User Manuals, Package Inserts, and Quick Reference Guides, while collaborating with Regulatory Affairs, Engineering, Quality, and Marketing to ensure documentation is in alignment with product requirements.
Authoring content in MadCap Flare while leveraging variables, condition tags, snippets, content reuse strategies, and multi‑channel publishing outputs (PDF).
Ensuring documentation complies with applicable label requirements.
Participating in the design control activities including reviewing design inputs/outputs, risk management documentation, verification, and validation documentation, while aligning this with IFU content.
Processing documentation changes through formal change control (ECO).
Maintaining consistency across document sets and product families.
Contributing to continuous improvement of templates, style guides, and publishing workflows.
Competency
Be detail‑oriented with a strong focus on quality.
Possess the ability to manage simultaneous projects and strengths in cross‑functional collaboration.
Be “regulated aware” in mindset with risk‑based thinking capabilities.
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This requires a W2‑paid employee local to the Boston area within a commutable distance and ability to be in office 3 days weekly. Ideal candidate will be willing to start as a consultant and then move into permanent employment after 6 months.
$35 - $50 W2 hourly pay based on individual and expertise.
A 6‑month contract with the potential to convert to a permanent position.
Base Compensation ranges from $80,000 to $98,000 based on individual and expertise.
Urgent role with a desired start in March 2026.
Requirements
Bachelor’s Degree in English or Technical Writing.
3+ years’ experience as technical writer in Life Sciences Industries, ideally Medical Devices or In Vitro.
Located within the greater Boston area and able to commute onsite 3 days per week.
Advanced expertise in MadCap Flare to include project architecture, conditional text, variables, and content reuse strategy.
Expertise in Quality Management Systems (QMS).
Familiarity with global labeling requirements to include FDA, EU MDR, IVDR, Health Canada, etc.
Preferred Expertise
Experience in Adobe Acrobat and FrameMaker, and other graphics tools.
Knowledge of Smartsheet is highly desired.
Responsibilities
Authoring, revising, and maintaining end‑user documentation in compliance with regulatory and quality system requirements.
Developing, editing, and maintaining Instructions for Use (IFUs), User Manuals, Package Inserts, and Quick Reference Guides, while collaborating with Regulatory Affairs, Engineering, Quality, and Marketing to ensure documentation is in alignment with product requirements.
Authoring content in MadCap Flare while leveraging variables, condition tags, snippets, content reuse strategies, and multi‑channel publishing outputs (PDF).
Ensuring documentation complies with applicable label requirements.
Participating in the design control activities including reviewing design inputs/outputs, risk management documentation, verification, and validation documentation, while aligning this with IFU content.
Processing documentation changes through formal change control (ECO).
Maintaining consistency across document sets and product families.
Contributing to continuous improvement of templates, style guides, and publishing workflows.
Competency
Be detail‑oriented with a strong focus on quality.
Possess the ability to manage simultaneous projects and strengths in cross‑functional collaboration.
Be “regulated aware” in mindset with risk‑based thinking capabilities.
#J-18808-Ljbffr