Medical Device Technical Writer SME - Ciudad Juárez - BEPC Inc. - Business Excellence Professional Consulting

Descripción

BEPC Inc. provides Specialized Engineering Solutions and IT Project Management services to Fortune 500 companies in the Life Science and Technology industries. BEPC Mexico, a division of BEPC Incorporated, provides and manages consulting services for Automotive and Medical device companies throughout Mexico and around the globe.

We are seeking a highly experienced Medical Device Technical Writer SME with deep expertise in the medical device industry and regulated environments. This role serves as a subject matter expert (SME) in technical documentation and regulatory compliance, providing strategic leadership in documentation standards, quality systems alignment, and cross-functional documentation governance.

The Medical Device Technical Writer SME will lead complex documentation initiatives, drive standardization across programs, and ensure compliance with FDA, ISO 13485, GMP, and other global regulatory requirements. This role operates with high autonomy and influences engineering, quality, regulatory, and executive stakeholders.

KEY RESPONSIBILITIES:

• Lead the development, review, and lifecycle management of complex controlled documentation, including:
• Design History Files (DHF)
• Device Master Records (DMR)
• Validation protocols and reports (IQ/OQ/PQ)
• Risk management documentation (ISO
• SOPs, Work Instructions, and Quality System documentation
• Regulatory submission documentation (e.g., 510(k), PMA, Technical Files)
• Serve as documentation SME for regulatory compliance (FDA 21 CFR Part 820 / QMSR, ISO 13485, EU MDR).
• Establish and standardize documentation frameworks, templates, and governance processes across programs.
• Lead documentation strategy for NPI, remediation, design changes, and audit readiness initiatives.
• Partner with Engineering, Quality, Regulatory Affairs, Clinical, and Manufacturing leadership to ensure alignment of documentation with technical and regulatory requirements.
• Support internal and external audits (FDA, Notified Bodies) and lead documentation responses.
• Oversee document control processes and ensure effective use of eDMS systems.
• Mentor and provide technical guidance to senior and junior technical writers.
• Identify gaps in documentation systems and drive continuous improvement initiatives.
• Review and redline engineering drawings, templates and BOMs.

QUALIFICATIONS:

• Bachelor's degree in Engineering, Life Sciences, Technical Communication, or related field (Master's preferred).
• 10+ years of technical writing experience in medical devices or highly regulated industry.
• Extensive experience with: FDA 21 CFR Part 820 / QMSR, ISO 13485, ISO 14971 and GMP environments
• Experience in Validation documentation (IQ/OQ/PQ).
• Demonstrated experience leading documentation efforts for: NPI programs, Remediation projects, Regulatory submissions and Audit preparedness initiatives.
• Deep knowledge of DHF, DMR, DHR structures.
• Experience with eDMS platforms (MasterControl, Veeva, Agile, TrackWise, etc.).
• Exceptional technical writing, editing, and stakeholder communication skills.