Senior Quality & Regulatory Affairs Consultant (Medical Devices)

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

• Bachelor’s degree in a science discipline such as biomedical engineering, Quality engineering, microbiology or chemistry 
• Atleast 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
• Experience with registration of medical device, IVD and SaMDs with CDSCO, India
• Experience with writing and compiling technical documentation.
• Experience with risk management files (ISO 14971).
• Client-facing experience and strong interpersonal skills.

• Professional level written and verbal English and excellent communication skills

   

   

  OTHER DESIRED COMPETENCY AND QUALIFICATIONS:

• Post-graduate degree.
• Lead auditing experience (QMSR, ISO 13485, MDSAP).
• Documented experience with software is considered as an additional advantage.
• Experience with presenting training to groups.
• Fluency in additional languages.
• Previous medical device consulting experience

• RAPS Certification