Technical FDA Writer

About the role

The Technical FDA Writer is responsible for authoring, revising, and maintaining the controlled documentation that underpins MMO's Quality Management System (QMS). This role owns the drafting and revision of Standard Operating Procedures (SOPs), Work Instructions (WIs), Playbooks (PBs), forms, and supporting quality documentation used across MMO's operational sites in support of FDA 21 CFR Part 820 (QMSR) and ISO 13485:2016 compliance. This role works cross-functionally with Quality, Operations, IT, and customer program owners to translate regulatory requirements and operational realities into clear, defensible, audit-ready documentation. The Technical FDA Writer is a mid-level individual contributor role and a critical link between MMO's operational teams and its regulatory posture. The right person is a strong writer with medical device regulatory grounding, comfortable with complex operational subject matter, and rigorous about document control discipline.

Key Responsibilities

QMS Documentation Authoring

• SOP authoring and revision — Draft new SOPs and revise existing SOPs (including but not limited to the SOP-OB-INTL series and all department-level SOPs) in alignment with QMSR / ISO 13485 requirements and MMO's document control conventions.
• Work Instruction development — Author WIs (including the WI-OB-INTL series and equivalents) that translate SOP-level requirements into operator-executable steps with appropriate visual aids, checklists, and decision criteria.
• Playbook authoring — Develop Playbooks (PB-OB-INTL and equivalents) that provide role-based operational guidance combining process, tools, escalation paths, and success criteria.
• Forms and templates — Create and maintain controlled forms, templates, and record structures that support consistent execution and audit-defensible recordkeeping.
• MMO Quality Manual maintenance — Support the Quality Manager in maintaining the MMO Quality Manual and top-level QMS documentation, including revisions triggered by regulatory updates, organizational changes, or continuous improvement initiatives.

Document Control and Change Management

• Document lifecycle management — Manage documents through the full lifecycle: draft, review, approval, effective date, revision, and obsolescence, in accordance with MMO's document control procedure.
• Change control coordination — Prepare change control packages for QMS document changes, including impact assessments, training requirements, and effective date planning.
• Reference document integration — Support the implementation of the Authorized Reference Model where customer-owned procedures are referenced within MMO's QMS; author the master procedure and per-program authorization documents that establish this framework.

Regulatory Alignment and Continuous Improvement

• Regulatory currency — Monitor updates to FDA 21 CFR Part 820 (QMSR), ISO 13485:2016, and applicable guidance documents; translate changes into required QMS document updates in partnership with Quality and Regulatory Affairs.
• Gap analysis support — Support periodic gap analyses of the MMO QMS against regulatory requirements and customer quality agreement provisions; author remediation documentation as required.
• Continuous improvement — Identify and propose improvements to document structure, readability, and usability based on operator feedback, audit findings, and industry best practices.
• Training material authoring — Develop or support the development of training materials linked to controlled procedures, including quick reference guides, decision trees, and job aids.

Audit Support and Response

• Customer quality agreement support — Support the drafting and revision of Quality Agreements between MMO and customer manufacturers, with attention to document control, records ownership, and change communication provisions.

Cross-Functional Collaboration

• Operations partnership — Partner with Operations, CSA International, and site leadership to understand actual process execution and ensure documentation reflects operational reality.
• Quality partnership — Work closely with the Quality Manager and Quality Engineers on documentation strategy, review workflows, and regulatory interpretation.
• Customer program support — Support customer program onboarding by authoring customer-specific procedures, work instructions, and reference documents required for new programs.

Minimum Qualifications

• Bachelor's degree required in Life Sciences, Engineering, Regulatory Affairs, Technical Communication, English, or a related field.
• 3–7 years of technical writing experience in 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) is required.
• Experience with medical device 3PL, contract manufacturing, or supply chain operations is strongly preferred.

Technical Skills

• Regulatory knowledge — Working knowledge of QMSR / 21 CFR Part 820, ISO 13485:2016, and 21 CFR Part 11 (electronic records).
• Document control — Proficient with electronic document management systems (e.g., MasterControl, Veeva QualityDocs, Greenlight Guru, ETQ, or equivalent).
• Authoring tools — Advanced proficiency with Microsoft Word (styles, cross-references, templates), Visio or Lucidchart for process flow diagrams, and PDF finalization workflows.
• Collaboration tools — Proficiency with Microsoft 365 (Teams, SharePoint, OneDrive) for collaborative document development and controlled distribution.
• Change control tools — Familiarity with change control workflow tools and impact assessment methodologies.

Certifications (Preferred)

• RAC (Regulatory Affairs Certification) from RAPS is a strong plus.
• ASQ CQA (Certified Quality Auditor) or CQE (Certified Quality Engineer) is a plus.
• Technical writing certifications (STC, or vendor-specific such as MadCap) are a plus.
• Lean Six Sigma Green Belt or equivalent is a plus for process documentation work.

Working Conditions

• Physical requirements — Primarily office-based; occasional walking of warehouse floor to observe operations that are being documented. May require use of PPE when observing operations in controlled areas.
• Travel — Occasional travel between MMO sites (Fall River, Olive Branch, Bloomfield, West Warwick) for stakeholder engagement and process observation. Estimated travel: up to 10% of time.