Technical FDA Writer

Millstone Medical•Olive Branch, MS

22d•Hybrid

About The Position

Millstone Medical is seeking a Technical FDA Writer to author, revise, and maintain controlled documentation for their Quality Management System (QMS). This role involves creating Standard Operating Procedures (SOPs), Work Instructions (WIs), Playbooks (PBs), forms, and other quality documentation to ensure compliance with FDA 21 CFR Part 820 (QMSR) and ISO 13485:2016. The Technical FDA Writer will collaborate with Quality, Operations, IT, and customer representatives to translate regulatory requirements and operational processes into clear, accurate, and audit-ready documentation. This is a mid-level individual contributor position requiring strong writing skills, medical device regulatory knowledge, and a meticulous approach to document control.

Requirements

Bachelor's degree in Life Sciences, Engineering, Regulatory Affairs, Technical Communication, English, or a related field.
3–7 years of technical writing experience in a medical device, pharmaceutical, or FDA-regulated manufacturing environment.
Demonstrated experience authoring SOPs, Work Instructions, and controlled procedures within a QMS.
Direct experience with 21 CFR Part 820 (QMSR) and ISO 13485:2016 documentation requirements.
Experience supporting audits (FDA, ISO certification body, or customer audits).
Working knowledge of QMSR / 21 CFR Part 820, ISO 13485:2016, and 21 CFR Part 11 (electronic records).
Proficiency with electronic document management systems (e.g., MasterControl, Veeva QualityDocs, Greenlight Guru, ETQ, or equivalent).
Advanced proficiency with Microsoft Word (styles, cross-references, templates).
Proficiency with Visio or Lucidchart for process flow diagrams.
Proficiency with PDF finalization workflows.
Proficiency with Microsoft 365 (Teams, SharePoint, OneDrive) for collaborative document development and controlled distribution.
Familiarity with change control workflow tools and impact assessment methodologies.

Nice To Haves

Advanced degree (e.g., MS in Regulatory Affairs, Technical Communication, or related).
Experience with medical device 3PL, contract manufacturing, or supply chain operations.
RAC (Regulatory Affairs Certification) from RAPS.
ASQ CQA (Certified Quality Auditor) or CQE (Certified Quality Engineer).
Technical writing certifications (STC, or vendor-specific such as MadCap).
Lean Six Sigma Green Belt or equivalent.

Responsibilities

Authoring and revising SOPs, Work Instructions, and Playbooks in alignment with QMSR/ISO 13485 requirements and document control conventions.
Creating and maintaining controlled forms, templates, and record structures.
Supporting the maintenance of the MMO Quality Manual and top-level QMS documentation.
Managing documents through their full lifecycle: draft, review, approval, effective date, revision, and obsolescence.
Coordinating change control packages for QMS document changes, including impact assessments and training requirements.
Supporting the implementation of the Authorized Reference Model for customer-owned procedures.
Monitoring updates to FDA 21 CFR Part 820 (QMSR), ISO 13485:2016, and relevant guidance documents, and translating changes into QMS document updates.
Supporting gap analyses of the MMO QMS against regulatory requirements and customer quality agreements.
Identifying and proposing improvements to document structure, readability, and usability.
Developing or supporting the development of training materials linked to controlled procedures.
Supporting the drafting and revision of Quality Agreements between MMO and customer manufacturers.
Partnering with Operations, CSA International, and site leadership to ensure documentation reflects actual process execution.
Collaborating closely with the Quality Manager and Quality Engineers on documentation strategy and regulatory interpretation.
Supporting customer program onboarding by authoring customer-specific procedures and work instructions.