Document Control Specialist - Medical Device #2902

About the role

The Senior Technical Writer is responsible for creating, editing, and maintaining high-quality documentation that supports the development, regulatory approval, and use of medical devices. This includes user manuals, design documentation, labeling, and regulatory submissions in compliance with global standards.

Responsibilities

• Develop and maintain technical documentation such as: User manuals and instructions for use (IFU), Design history files (DHF), Device master records (DMR), Standard operating procedures (SOPs)
• Ensure documentation complies with regulatory standards such as FDA and ISO (e.g., ISO 13485, ISO 14971)
• Collaborate with cross-functional teams (engineering, quality, regulatory, clinical)
• Translate complex technical and scientific information into clear, user-friendly content
• Support regulatory submissions (e.g., 510(k), CE marking)
• Maintain document control processes and versioning
• Review and edit documents for accuracy, consistency, and compliance
• Participate in risk management and usability documentation

Requirements

• Bachelor’s degree in Technical Writing, Engineering, Life Sciences, or related field
• 5+ years of experience in technical writing, preferably in medical devices or healthcare
• Strong understanding of medical device regulations and standards
• Excellent writing, editing, and communication skills
• Familiarity with document management systems and tools
• Experience with regulatory frameworks such as: 21 CFR Part 820, EU MDR
• Knowledge of usability engineering and risk management processes
• Experience with tools like: Microsoft Word, Adobe Acrobat, XML/DITA authoring systems
• Ability to manage multiple projects and deadlines

Qualifications

• Ability to manage multiple projects and deadlines

Skills

• Technical Writing
• Medical Devices
• Regulatory Compliance
• Document Management Systems
• Usability Engineering
• Risk Management
• Microsoft Word
• Adobe Acrobat
• XML/DITA Authoring Systems

Benefits

• Flexible employment & benefit options

Pay

• Competitive salary based on experience and qualifications

Schedule

• Full-time position

ECI is an equal opportunity employer. All qualified applicants will receive consideration for employment at ECI without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. All candidates must be authorized to work in the U.S. without the need for employment-based visa sponsorship from ECI another 3rd party vendor.