Senior Quality & Regulatory Affairs Consultant - #10489440

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., Brazil registrations 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 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 addressing and responding to deficiencies of product submissions identified by regulatory authorities
• Guidance on testing requirements to support marketing submissions

Provide Quality Assurance consulting services, such as:

• Implementation of Quality Management System (QMS)
• 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
• Review and advise on labeling and marketing materials, including written documents and website
• Read and follow the Underwriters Laboratories Code of Conduct, and follow all physical and digital security practices