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