Position:
Sr. Executive - QA (RA & NPD)
Department:
Category:
Quality Assurance
Staff
Job Purpose:
Responsible for updating QMS procedures, creating new documents and updating Quality Manual with
regard to latest guidelines/regulatory requirements/applicable product standards.
Relevant Experience:
Reporting to:
3- 5 Years
AGM
Responsible for product submissions – domestic and international, registration renewals, seeking periodic
updates and dossier preparation for regulatory agencies.
Organize regulatory information, track and control submissions, review and advise on labeling for
compliance with regulatory filings, review product changes for impact on regulatory filings worldwide and
research regulatory issues and provide guidance to colleagues.
Functional Responsibilities:
Timely compile Product Technical Files/ QA records required for renewals, updates and registrations.
Update and maintain UDI (GTIN) barcode log sheet and registration certificates log sheet – client wise.
Maintain regulatory files /database and chronologies in good order.
Review art designs and labels for compliance with regulatory and customer requirements.
Review changes to existing products and processes to define the requirements for regulatory submissions.
Routinely review changes in the regulatory framework such as USFDA, EU, ROW, CIS, India etc. and product
standards ,update the list of product standards in a timely manner, wherever applicable.
Represent Regulatory Affairs on product development project teams to ensure all regulatory requirements
are met throughout the development process.
Complete submissions to all countries wherever products are expected to be launched / placed in the
market.
Keeping self, regularly updated through subscriptions and relevant online forum updates.
Actively pitch-in daily QA department affairs, participate and contribute in inter-departmental requests.
Competencies
B.Tech/B. Pharma/B.Sc with 3-5 yrs of experience in Regulatory Affairs /Quality Assurance.
Any certification or full time course in Regulatory Affairs/QA
Knowledge of Quality Management Systems and regulations e.g. ISO 13485, ISO 9001,
21 CFR 820, MDR 745.
Fair communication skills and computers skills, able to work with basic MS office
Experience in Medical device Industry will be a bonus.
Result orientation
Customer-centricity
