We are seeking experienced Design Controls and Design History File (DHF) Remediation Specialists to support medical device manufacturers with quality system and product lifecycle compliance initiatives. The successful candidate will serve as a subject matter expert in Design Controls, Risk Management, Design Assurance, and Quality Systems, supporting remediation and reconstruction of Design History Files (DHF), Technical Documentation, and associated records to ensure compliance with FDA, ISO 13485, MDR, and other applicable regulatory requirements. This role requires strong technical writing, regulatory interpretation, project leadership, and cross-functional collaboration skills.

Key Responsibilities

Design Controls & DHF Remediation
- Perform assessments of Design History Files (DHF) and Design Control documentation for compliance with FDA, ISO 13485, and company procedures.
- Identify documentation gaps and develop remediation plans to address deficiencies.
- Create, review, update, and remediate Design Control deliverables, including:
- Design and Development Plans
- User Needs




- Intended Use Statements
- Design Inputs
- Design Outputs
- Design Reviews
- Verification Documentation
- Validation Documentation
- Design Transfer Documentation
- Design Change Records
- Traceability Matrices
- Design History Files (DHF)
- Ensure complete traceability between user needs, design inputs, risk controls, verification, validation, and product requirements.
- Support legacy product remediation and historical design documentation reconstruction activities.

Quality & Regulatory Compliance
- Support Quality Assurance (QA) and Regulatory Affairs (RA) activities for medical device manufacturers.
- Ensure compliance with applicable regulations and standards, including:
- FDA 21 CFR Part 820 and Design Controls
- ISO 13485
- ISO 14971 Risk Management
- IEC 62304
- EU MDR 2017/745
- EU MDR and IVDR
- Applicable FDA guidance documents
- Support remediation programs resulting from

📌 Remote DHF Remediation Specialist Medical Devices (Ciudad de México)
🏢 Pqe Group
📍 Ciudad de México