MedCap Flare Tech Writer
Black Diamond Networks
Boston, MA
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JOB DETAILS
JOB TYPE
Temporary, Contractor, Full-time
SKILLS
Adobe Acrobat, Adobe FrameMaker, Biology, Change Control, Communication Skills, Content Filtering Software, Content Structure, Cross-Functional, Document Management, Documentation, English Language, FDA Requirements, Graphics, Health Canada, Marketing, Medical Equipment, Multitasking, Presentation/Verbal Skills, Project/Program Management, Quality Engineering, Quality System Requirements (QSR), Regulations, Regulatory Compliance, Risk, Source Code/Configuration Management (SCM), Technical Writing, User Documentation, Validation Documentation, Validation Testing, Writing Skills
LOCATION
Boston, MA
POSTED
3 days ago
Location: Boston area, MA (Hybrid) – 3 days a week onsite, 2 remote
Duration: 6 months
Start Date: March 30th
JOB SCOPE:
The Technical Writer will be responsible for authoring, revising, and maintaining end-user documentation for medical devices in compliance with applicable regulatory and quality system requirements. This person will support documentation such as Instructions for Use, User Manuals, Package Inserts, and Quick Reference Guides. The role requires strong experience with MadCap Flare and structured content development, including reusable content strategies, variables, condition tags, and multi-channel publishing outputs. The writer will collaborate cross-functionally with Regulatory Affairs, Engineering, Quality, and Marketing to ensure documentation accuracy, consistency, and compliance. This individual will also participate in design control activities, review risk and verification/validation documentation, and process updates through formal change control.
Include Must Have Skills:
• 3–5+ years of technical writing experience within medical device, IVD, or life sciences
• Strong experience authoring end-user documentation such as IFUs, user manuals, package inserts, and quick reference guides
• Advanced proficiency with MadCap Flare
• Experience with structured content, version control, variables, condition tags, snippets, and content reuse strategies
• Experience working within an FDA- and ISO-regulated environment
• Understanding of QMS and controlled documentation processes
• Experience supporting change control / ECO processes
• Strong written and verbal communication skills
• Ability to work cross-functionally with Regulatory, Quality, Engineering, and Marketing
• Ability to manage multiple concurrent projects independently
Education Requirements:
• Bachelor’s degree or higher in English, Technical Writing, or related field
Nice to have skills:
• Familiarity with global labeling requirements including FDA, EU MDR, IVDR, and Health Canada
• Experience with Adobe Acrobat
• Experience with Adobe FrameMaker
• Experience with graphics tools
• Knowledge of Smartsheet
About the Company
B
Black Diamond Networks
INDUSTRY
Biotechnology/Pharmaceuticals