Technical Document Reviewer

Merck KGaA • Saint Louis, MO

55d

About The Position

At MilliporeSigma, as the Technical Document Reviewer, you have responsibility for reviewing technical documents related to invitro diagnostic (IVD) products, ensuring accuracy, compliance with regulatory standards, and alignment with internal quality guidelines. The role will involve assessing content, structure, and clarity of product documentation, ensuring they meet both internal and external requirements.

Requirements

• Bachelor's Degree in a scientific discipline (e.g., Biology, Chemistry, Microbiology, etc.)

Nice To Haves

• 1+ years experience in reviewing technical documentation
• Experience in reviewing technical documentation within the medical device, healthcare, or pharmaceutical industry
• Familiarity with regulatory requirements for medical device documentation
• Attention to detail and strong analytical skills
• Proficiency in reviewing technical content for clarity, accuracy, and compliance with internal guidelines and industry standards
• Highly developed interpersonal, written, and verbal communication skills
• Ability to work autonomously, effectively manage time and deliver results on time
• Strong organizational skills and ability to handle multiple projects simultaneously in a fast paced environment
• Ability to work collaboratively in cross-functional teams and manager stakeholder expectations

Responsibilities

• Review technical documentation, including product manuals, instructions for use, product specifications, risk management files, regulatory submissions and other related documents to ensure accuracy, clarity and compliance with regulatory requirements, including ISO 13485, IVDR, and other applicable standards.
• Assess the quality of documents, ensuring they are well-structured, free of errors, consistent in terminology, and aligned with internal style guides and templates.
• Collaborate with team members to ensure documents accurately reflect product functionality, design and regulatory requirements.
• Verify the accuracy of technical content and ensure consistency across all documents, including terminology, format and style.
• Manage version control and ensure that the most current documents are being reviewed and approved. Maintain an organized system for tracking document revisions and updates.
• Provide detailed feedback to document authors regarding document structure and content clarity. Suggest edits, revisions or additions to improve document quality.
• Participate in customer and regulatory audits, as a Subject Matter Expert of applicable Quality Management System(s)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Number of Employees: 5,001-10,000 employees