The Senior Quality & Regulatory Affairs Consultant will work within Emergo’s consulting team, providing assistance with regulatory and quality compliance issues to clients in accordance with written Work Instructions and the signed proposal / SOW.

Responsibilities
Provide Quality and/or Regulatory consulting services, independently or with oversight by a Lead QA/RA Consultant or Consultant Manager, which may include but are not limited to:
• Leverage regulatory affairs experience gained in the medical device industry/medical device consulting to provide client support with Quality Assurance and Regulatory compliance requests, help resolve client issues, and respond to market-specific inquiries.
• Prepare/review local or international regulatory submissions e.g., FDA 510(k) for or on behalf of manufacturers, demonstrate and share knowledge of requirements by market and compile/review technical documentation files for compliance to applicable regulations; raise concerns where any are identified, provide guidance for resolution.




• Perform research on regulatory affairs requested for standard or nuanced market environments and generate peer reviewed reports.
• Provide Quality Assurance consulting services, such as: • Implementation of new Quality Management System (QMS) to ISO 13485, QSR, MDSAP, EU regulations, etc.
• Draw from medical device industry experience for analysis of existing client QMS against requirements and gap closure and remediation as needed
• Conduct Internal audits / Supplier audits for manufacturers, distributors and vendors
• Maintenance and/or updating of QMS with additional requirements (e.g., MDSAP, EU MDR/IVDR)

• Provide Regulatory consulting services, such as: • Research and prepare regulatory classification and strategy / pathway reports
• Review and identify gaps in technical / regulatory documentation
• Prepare premarket submissions to regulatory authorities
• Perform literature searches and prepare Clinical Evaluation Reports
• Assist in

📌 Senior Quality (México)
🏢 UL Solutions
📍 México