Senior Quality & Regulatory Affairs consultant – Emergo by UL, India (This role is based out of India)
Job 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 area to provide hands-on support to manufacturers with Quality Assurance and Regulatory compliance requests, help resolve client issues, and respond to market-specific inquiries. This role involves regular and frequent interaction with our clients, appropriate communication skills and experience are a must.
- Prepare/review local or international regulatory submissions e.g., India, South East Asia, EU/USA markets 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, QMSR, 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
