Technical Writer
Actalent, Boston, MA, United States
Description
Summary: The Technical Writer is responsible for authoring, revising, and maintaining end-user documentation for medical devices in compliance with applicable regulatory and quality system requirements. The ideal candidate has demonstrated experience working within FDA- and ISO-regulated environments and is highly proficient in MadCap Flare for structured, reusable content development. This individual operates with moderate independence and partners cross-functionally to ensure documentation accuracy, regulatory compliance, and consistency across product lines.
Key Responsibilities
Develop and maintain:
Instructions for Use (IFUs)
User Manuals
Package Inserts
Quick Reference Guides
Author content in MadCap Flare, leveraging:
Variables and condition tags
Snippets and content reuse strategies
Multi-channel publishing outputs (primarily PDF)
Ensure documentation complies with the applicable labeling requirements
Participate in design control activities, including review of:
Design inputs and outputs
Risk management documentation
Verification and validation documentation for alignment with IFU content
Process documentation changes through formal change control (ECO)
Collaborate closely with Regulatory Affairs, Engineering, Quality, and Marketing to ensure documentation alignment with product requirements
Maintain consistency across document sets and product families
Contribute to continuous improvement of templates, style guides, and publishing workflows
Skills Technical writing, Medical writing, Regulatory, Writing skills, qms, madcap flare, Medical
Top Skills Details Technical writing,Medical writing,Regulatory,Writing skills,qms,madcap flare
Additional Skills & Qualifications
Required Qualifications:
Bachelor's Degree, or higher in English or Technical Writing
Minimum 3-5 years of experience as a technical writer within an IVD/Medical Device Business (Life sciences)
Experience working within a Quality Management System (QMS)
Strong understanding of structured documentation and version control
Experience in medical device industry, regulations and governance requirements
Advanced proficiency in MadCap Flare, including project architecture, conditional text, variables, and content reuse strategy
Strong written and verbal communication skills
Preferred Qualifications:
Familiarity with global labeling requirements (FDA, EU MDR, IVDR, Health Canada, etc)
Experience with Adobe Acrobat, Adobe FrameMaker, and graphics tools
Knowledge of Smartsheet is highly desired
Core Competencies:
Detail-oriented with strong quality focus
Ability to manage multiple concurrent projects
Strong cross-functional collaboration skills
Regulatory awareness and risk-based thinking
Process-oriented mindset
Ability to work independently with minimal supervision
Experience Level Intermediate Level
Job Type & Location This is a Contract position based out of Boston, MA.
Pay and Benefits The pay range for this position is $40.00 - $47.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms.
Medical, dental & vision
Critical Illness, Accident, and Hospital
401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
Life Insurance (Voluntary Life & AD&D for the employee and dependents)
Short and long-term disability
Health Spending Account (HSA)
Transportation benefits
Employee Assistance Program
Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type This is a hybrid position in Boston,MA.
Application Deadline This position is anticipated to close on Mar 20, 2026.
About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.
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Key Responsibilities
Develop and maintain:
Instructions for Use (IFUs)
User Manuals
Package Inserts
Quick Reference Guides
Author content in MadCap Flare, leveraging:
Variables and condition tags
Snippets and content reuse strategies
Multi-channel publishing outputs (primarily PDF)
Ensure documentation complies with the applicable labeling requirements
Participate in design control activities, including review of:
Design inputs and outputs
Risk management documentation
Verification and validation documentation for alignment with IFU content
Process documentation changes through formal change control (ECO)
Collaborate closely with Regulatory Affairs, Engineering, Quality, and Marketing to ensure documentation alignment with product requirements
Maintain consistency across document sets and product families
Contribute to continuous improvement of templates, style guides, and publishing workflows
Skills Technical writing, Medical writing, Regulatory, Writing skills, qms, madcap flare, Medical
Top Skills Details Technical writing,Medical writing,Regulatory,Writing skills,qms,madcap flare
Additional Skills & Qualifications
Required Qualifications:
Bachelor's Degree, or higher in English or Technical Writing
Minimum 3-5 years of experience as a technical writer within an IVD/Medical Device Business (Life sciences)
Experience working within a Quality Management System (QMS)
Strong understanding of structured documentation and version control
Experience in medical device industry, regulations and governance requirements
Advanced proficiency in MadCap Flare, including project architecture, conditional text, variables, and content reuse strategy
Strong written and verbal communication skills
Preferred Qualifications:
Familiarity with global labeling requirements (FDA, EU MDR, IVDR, Health Canada, etc)
Experience with Adobe Acrobat, Adobe FrameMaker, and graphics tools
Knowledge of Smartsheet is highly desired
Core Competencies:
Detail-oriented with strong quality focus
Ability to manage multiple concurrent projects
Strong cross-functional collaboration skills
Regulatory awareness and risk-based thinking
Process-oriented mindset
Ability to work independently with minimal supervision
Experience Level Intermediate Level
Job Type & Location This is a Contract position based out of Boston, MA.
Pay and Benefits The pay range for this position is $40.00 - $47.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms.
Medical, dental & vision
Critical Illness, Accident, and Hospital
401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
Life Insurance (Voluntary Life & AD&D for the employee and dependents)
Short and long-term disability
Health Spending Account (HSA)
Transportation benefits
Employee Assistance Program
Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type This is a hybrid position in Boston,MA.
Application Deadline This position is anticipated to close on Mar 20, 2026.
About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.
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