Work Your Magic with us! Start your next chapter and join MilliporeSigma.
Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.
Your Role:
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.
Key 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)
Who You Are:
Minimum Qualifications:
Bachelor’s Degree in a scientific discipline (e.g., Biology, Chemistry, Microbiology, etc.) or a technical discipline (e.g., Computer Science, Data Science, etc. )1+ years experience in reviewing technical documentation
Preferred Qualifications:
Experience in reviewing technical documentation within the medical device, healthcare, or pharmaceutical industry. Familiarity with regulatory requirements for medical device documentationAttention to detail and strong analytical skillsProficiency in reviewing technical content for clarity, accuracy, and compliance with internal guidelines and industry standardsHighly developed interpersonal, written, and verbal communication skillsAbility to work autonomously, effectively manage time and deliver results on timeStrong organizational skills and ability to handle multiple projects simultaneously in a fast paced environmentAbility to work collaboratively in cross-functional teams and manager stakeholder expectations
RSREMD
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of our diverse team!
If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html