_:n89facee12fad4b1a8d3fa220f6e9fb01xb0
<http://schema.org/responsibilities>
"Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer. The position involves applying experience in product development, quality and regulatory documentation to support the R&D team in drafting documentation for new product development towards regulatory submissions. Prepare new product development documentation including study plans/reports, SOPs, and other technical documents. Proofread and ensure documents meets Quality and Regulatory requirements, guidelines, policies, and procedures. Facilitate and track the document routing and approval in collaboration with Core Team members and Document Management System change analysts. Actively participates with cross-functional new product development teams to ensure documents are in compliance with design controls per ISO 13485 and FDA QSR. Generate templates and guidance documents in partnership with Regulatory and Clinical Affairs, Quality/Design Compliance and other stakeholders. Standardize and streamline documents and documentation system in coordination with R&D team and managers. Aid in preparation of documents for regulatory submission. Proactively solicit information from other experts within the company as needed (e.g. R&D, Manufacturing, QA, QC, Legal). Driven to deliver quality results on time and in a highly ethical and professional manner. "
<https://jobs.thermofisher.com/global/en/job/174462BR/In-Vitro-Diagnostics-IVD-Documentation-Specialist-Remote>