<p>Description</p> <p>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.</p> <p>Skills</p> <p>Technical writing, Medical writing, Regulatory, Writing skills, qms, madcap flare, Medical</p> <p>Top Skills Details</p> <p>Technical writing,Medical writing,Regulatory,Writing skills,qms,madcap flare</p> <p>Additional Skills & Qualifications</p> <p>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</p> <p>Experience Level</p> <p>Intermediate Level</p> <p>Job Type & Location</p> <p>This is a Contract position based out of Boston, MA.</p> <p>Pay and Benefits</p> <p>The pay range for this position is $40.00 - $47.00/hr.</p> <p>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:</p> <ul> <li>Medical, dental & vision </li><li>Critical Illness, Accident, and Hospital </li><li>401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available </li><li>Life Insurance (Voluntary Life & AD&D for the employee and dependents) </li><li>Short and long-term disability </li><li>Health Spending Account (HSA) </li><li>Transportation benefits </li><li>Employee Assistance Program </li><li>Time Off/Leave (PTO, Vacation or Sick Leave) </li></ul> <p>Workplace Type</p> <p>This is a hybrid position in Boston,MA.</p> <p>Application Deadline</p> <p>This position is anticipated to close on Apr 10, 2026.</p> <p>Diversity, Equity & Inclusion</p> <p>At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through:</p> <ul> <li>Hiring diverse talent </li><li>Maintaining an inclusive environment through persistent self-reflection </li><li>Building a culture of care, engagement, and recognition with clear outcomes </li><li>Ensuring growth opportunities for our people </li></ul> <p>Actalent is an equal opportunity employer.</p> <p>About Actalent</p> <p>Actalent is a global leader in engineering and sciences services. For more than 40 years, we've helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC-with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day.</p> <p>Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.</p>