Quality & Regulatory Documentation Specialist

Required Skills & Experience

Experience supporting Quality and Regulatory documentation within a regulated environment. Strong understanding of document control, quality records, and regulatory documentation practices. Experience gathering, organizing, reviewing, and maintaining documentation and supporting records. Strong attention to detail with the ability to identify missing, incomplete, or inconsistent documentation. Ability to manage multiple documentation requests, stakeholders, and competing deadlines simultaneously. Strong written and verbal communication skills. Experience working cross-functionally with Quality, Regulatory Affairs, and other internal teams. Proficiency with Microsoft Word, Excel, and Outlook. Strong commitment to accuracy, traceability, confidentiality, and procedural compliance.

Nice to Have Skills & Experience

Previous experience serving as a central point of contact for Quality or Regulatory documentation requests. Experience reviewing documentation packages for completeness, approvals, consistency, and compliance prior to submission. Experience maintaining organized Quality or Regulatory documentation repositories. Experience working in a highly regulated industry where documentation accuracy and compliance are critical.

Job Description

A Client is seeking a Quality & Regulatory Documentation Specialist to support approximately 50% Quality activities and 50% Regulatory documentation activities, helping coordinate and respond to documentation requests across the organization. This individual will partner closely with Quality, Regulatory Affairs, and other internal stakeholders to ensure documentation is accurate, complete, organized, and delivered within required timelines. Key responsibilities will include coordinating Quality and Regulatory documentation requests, gathering and organizing supporting records, identifying required documentation, and working with internal teams to obtain complete and accurate information. The Specialist will review documentation packages for completeness, consistency, appropriate approvals, and alignment with applicable requirements prior to submission. This individual will also maintain organized documentation repositories, track outstanding requests and records, communicate status and potential risks, and proactively resolve documentation gaps. The ideal candidate is highly organized, detail-oriented, accountable, and comfortable managing multiple documentation requests in a deadline-driven, regulated environment.