Medical Device Technical Writer: 25-03652 - Akraya Inc.

Key Responsibilities:

• Write, edit, and maintain internal process documentation in line with company and regulatory standards.
• Provide writing support for teams transitioning to new templates and guidelines, developing process documentation flowcharts.
• Ensure compliance with Quality, Document Control, and Good Documentation Practice (GDP) guidelines.
• Act as lead writer on projects, mentoring other writers, keeping abreast of compliance requirements, sharing expertise, and participating in regulatory training.
• Manage multiple project deliverables under tight deadlines, prioritizing effectively and collaborating with project teams.

Must-Have Skills:

• Exceptional writing, editing, and grammar skills in a regulated environment.
• Strong organizational and time management capabilities.
• Proficiency in Microsoft Word and Visio, with a solid understanding of Adobe Illustrator or Photoshop.

Domain Experience:
Previous experience in the medical devices sector or other regulated environments is required, highlighting a deep understanding of the document control process and familiarity with decision tracking software like OneNote, Excel, and Smartsheet