Regulatory Compliance Consultant for Medical Device Organization

We are looking for an experienced Regulatory Compliance Consultant to support our U.S. FDA-registered medical device organization. The ideal candidate will have a solid understanding of FDA QSR/QMSR standards and the EU MDR frameworks, assisting in our transition to comply with the new regulations. This role involves reviewing existing processes, providing guidance, and ensuring that all quality management systems are aligned with both FDA and EU requirements. If you have a passion for medical devices and regulatory compliance, we want to hear from you!

Skills required:

- FDA QSR/QMSR knowledge

- EU MDR compliance

- Quality management systems (QMS)

- Medical device regulations

- Documentation and reporting

- Risk management analysis

This position is designed to support a U.S. FDA-registered medical-device organization operating under FDA QSR/QMSR (transition underway) and EU MDR frameworks. Responsibilities include the tasks outlined in the initial inquiry as well as the administrative and document-control activities necessary to maintain an FDA-regulated quality system.

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Technology & Tools in Use

Quality & Regulatory Systems

•QMS (cloud-based document control platform; currently transitioning to a MasterControl/Greenlight Guru–style structure)

• FDA Device Registration & Listing Portal

• FDA Industry Systems (FURLS/CDRH)

• 510(k) tracking templates and controlled documentation folders

• MDR-compliant technical file architecture

Business & Collaboration Tools

• Google Drive environment for controlled document libraries

• InfoPlus WMS (used in reference to UDI and labeling workflows)

• Google Workspace, Conversight AI reporting tool, and Slack

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Required Qualifications & Background

Regulatory / Compliance Familiarity

• Experience supporting FDA-regulated environments (21 CFR Part 820/QSR; familiarity with QMSR transition preferred)

• Understanding of medical-device documentation: DMR, DHF, DHR, labeling files, traceability, and UDI

• Exposure to EU MDR concepts, including PMS, PMCF, ISO 14971 risk-management files, GSPR, and technical file organization

Quality-System Support Skills

• Document control: revision control, versioning, formatting, and routed approvals

• Coordination of CAPA, NCR, and complaint-handling workflows

• Routing and documentation of change-control activities

• Preparation for internal, external, and supplier audits

• Supplier qualification and ongoing documentation maintenance

General Capabilities

• Strong organizational discipline and structured workflow habits

• Ability to manage recurring compliance calendars and deadline tracking

• High attention to detail

• Clear written communication suitable for controlled documents

• Ability to work effectively within a traceable, document-controlled environment

This role supports execution and organization within the regulatory framework and does not require authorship of regulatory submissions.

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