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 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 14971.

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 general 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 13485, ISO 14971, 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 62304, 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 (Ciudad de México)
🏢 Pqe Group
📍 Ciudad de México