Senior Quality & Regulatory Affairs Consultant
Location
São Paulo, SP | Brazil
Job description
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
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