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 *****, 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 *****, 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 *****
ISO ***** Risk Management
IEC *****
EU MDR ********
EU MDR and IVDR
Applicable FDA guidance documents
Support remediation programs resulting from audits, inspections, acquisitions, or quality system transformations.
Participate in audit readiness and regulatory inspection support activities.
Assist with CAPA investigations,



effectiveness checks, and remediation actions.
Develop, review, implement, and improve Quality Management System (QMS) procedures and work instructions.
Risk Management
Support development and remediation of Risk Management Files in accordance with ISO *****.
Review and update:
Risk Analyses
Hazard Analyses
FMEAs
Benefit-Risk Assessments
Risk Control Documentation
Ensure alignment and traceability between risk management activities and design control documentation.
Verification, Validation & Process Validation
Support Design Verification and Validation (V&V;) activities.
Develop, review, and execute validation documentation, including:
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)
Prepare validation reports and summary documentation.
Ensure documentation adequately demonstrates product and process compliance with specified requirements.
Regulatory Documentation & Product Lifecycle Support
Support preparation and remediation of technical documentation for U.S. and international submissions.
Contribute to:
CE Marking activities
MDR/IVDR compliance projects
Technical Documentation files
Labeling and IFU reviews
Design and Development activities
Support product registration activities in integral markets.
Participate in complaint investigations and post-market compliance activities.
Clinical and Post-Market Activities
Support:
Clinical Evaluation activities
Post-Market Surveillance (PMS)
Post-Market Clinical Follow-Up (PMCF)
Trend analysis and complaint investigations
Participate in investigations involving product quality, field performance, and cybersecurity-related complaints where applicable.




Project & Stakeholder Management
Participate in multiple concurrent projects while maintaining schedule, budget, and quality objectives.
Collaborate with cross-functional teams including:
R&D;
Engineering
Manufacturing
Supply Chain
Regulatory Affairs
Quality Assurance
Clinical Affairs
Operations
Prepare project deliverables, status reports, and remediation metrics.
Support client-facing meetings and communicate project progress and recommendations.
Training & Continuous Improvement
Provide guidance and training on:
Design Controls
DHF Requirements
Risk Management
CAPA
Quality System Requirements
Promote best practices for documentation, compliance, and product development processes.
Support quality system and process improvement initiatives.
Required Qualifications
Bachelor's degree in Engineering, Biomedical Engineering, Life Sciences, Quality, Regulatory Affairs, or related field.
Thorough understanding of FDA 21 CFR Part 820, Design Controls, ISO *****, ISO *****, MDR and/or IVDR.
Experience in Design Controls, Design Assurance, Quality Assurance, Regulatory Affairs, Product Development, or Medical Device Compliance.
Experience creating, reviewing, and revising controlled quality and technical documentation.
Strong technical writing, documentation review, analytical and communication skills.
Preferred Qualifications
Master's degree in Engineering, Life Sciences, Regulatory Affairs, or related discipline.
ASQ certifications (CQE, CQA, CMQ/OE) or equivalent.
Experience supporting FDA inspections, Notified Body audits, or remediation programs.
Experience with SaMD, IEC *****, IVDs, combination products, and Class II/III devices.
Core Competencies
Design Controls, DHF Remediation, FDA Compliance, Quality Systems, Regulatory Affairs, Design Assurance, Risk Management, CAPA, Verification & Validation, Process Validation (IQ/OQ/PQ), Technical Documentation, Traceability Analysis, Gap Assessments, Audit Readiness, MDR/IVDR Compliance, Project Management, Stakeholder Engagement, Technical Writing.

📌 Remote Dhf Remediation Specialist Medical Devices (México)
🏢 Pqe Group
📍 México