Provide hands-on Quality Assurance and Regulatory consulting for medical device manufacturers: prepare and review regulatory submissions (India, SEA, EU, USA), implement and assess QMS (ISO 13485, MDSAP, QMSR), perform internal and supplier audits, compile technical documentation and risk files (ISO 14971), support premarket submissions and responses, advise on labeling/testing, and deliver client-facing regulatory strategy and gap remediation.
JOB DESCRIPTION
Senior Quality & Regulatory Affairs consultant - Emergo by UL, India (This role is based out of India)
Job responsibilities
QUALIFICATIONS
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
QUALIFICATIONS
- 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
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