Confidential · 12 hours ago
Document Control Specialist
Confidential is a leader in the medical device and regulated life sciences industry, and they are seeking a dedicated Document Control Specialist to join their team. The role involves facilitating the Document Change Request process, managing document compliance, and supporting users with the electronic Documentation Management System.
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Responsibilities
Facilitate the Document Change Request (DCR) process, including review, coordination, approval, and implementation of document updates
Ensure all DCRs include impact assessments, approvals, training linkage, and implementation plans prior to document release
Manage timely processing, release, obsolescence, archival, and periodic review of documents in compliance with internal procedures and regulatory standards
Proofread and review documents within the Quality Management System to verify accuracy, effective dates, and adherence to Good Documentation Practices (GDP)
Support and guide document users on electronic Documentation Management System (eDMS), DCR processes, and troubleshooting system issues
Qualification
Required
Bachelor's Degree or equivalent in a related field or relevant work experience in document control or regulated industries
Minimum of 3 years of experience in document control within the medical device, pharmaceutical, or regulated life sciences industry
Hands-on experience with electronic Document Management Systems (eDMS) such as M-Files, MasterControl, Veeva, TrackWise DOC, or Documentum
Working knowledge of US FDA and ISO 13485 requirements is a MUST
Strong problem-solving, communication, organizational, and proofreading skills, with the ability to work independently and manage multiple priorities effectively
Benefits
Opportunity to contribute to a vital industry supporting health and safety standards.
Engage in a collaborative and inclusive work environment that values diversity and innovation.
Gain experience with leading electronic Document Management Systems and regulatory compliance processes.
Work remotely with flexible options to support work-life balance.
Be part of a company recognized for its commitment to ethical practices and employee development.