Senior Quality & Regulatory Affairs Consultant

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

• Bachelors' degree in a science discipline such as biomedical engineering, Quality engineering, microbiology or chemistry
• 5 years of Quality Assurance and Regulatory Affairs industry experience, ideally at a team lead / supervisory level.
• A demonstrated knowledge and understanding of global medical device regulations, especially MFDS, KGMP, MDSAP countries, and/or US.
• Experience with writing and compiling technical documentation.
• Experience with risk management files (ISO 14971).
• Client-facing experience and strong interpersonal skills.
• Fluency in English.

OTHER DESIRED COMPETENCY AND QUALIFICATIONS:

• Post-graduate degree.
• Lead auditing experience (QSR, ISO 13485, MDSAP).
• Experience with IVDs and/or device software / AI / SaMD a plus
• Experience with presenting training to groups.
• Fluency in additional languages.