Technical Writer

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: o Instructions for Use (IFUs) o User Manuals o Package Inserts o Quick Reference Guides
• Author content in MadCap Flare, leveraging: o Variables and condition tags o Snippets and content reuse strategies o Multi-channel publishing outputs (primarily PDF)
• Ensure documentation complies with the applicable labeling requirements
• Participate in design control activities, including review of: o Design inputs and outputs o Risk management documentation o 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. If eligible, the benefits available for this temporary role may include the following:

• 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 [email protected] for other accommodation options.