It s fun to work in a company where people truly BELIEVE in what they are doing We re committed to bringing passion and customer focus to the business The Regulatory Affairs Associate is an integral part of the Quality and Regulatory team The associate will be responsible for maintaining regulatory compliance via registrations document control being part of the internal and external audit team analysing data reporting trends and coordinating CAPA facilitation In addition the associate will provide regulatory support to product development quality and production with respect to design process and quality concerns Essential Functions Skills Communicates with regulatory authorities and or distributors to prepare and submit documentation for marketing approval in ASEAN Middle East and GCC Nations Co-ordinates with distributors for Medical Device registration in other parts of the world as and when required Performs research distribution storage tracking and retrieval of relevant information documents pertinent to the regulatory registrations and submissions Authors reviews and publishes paper and electronic submissions and communicates with regulatory authorities and government agencies Provides regulatory information and guidance for proposed product claims labelling Identifies the need for new regulatory procedures Operating Procedures and participates in development and implementation Helps train stakeholders on current and new quality and regulatory requirements to ensure organization-wide compliance Assists other departments in the development of Operating Procedures to ensure regulatory compliance Reviews proposed product changes for impact on regulatory status of the product Prepare record changes to controlled documents including formatting review and confirm changes with relevant departments prepare training material and coordinate with users to ensure electronic document processing is complete and document control is maintained and effective Performs other duties that are reasonably assigned Job Requirements A Bachelor s degree in a scientific discipline along with a minimum of 3 years regulatory affairs experience in a medical device setting is required Comprehensive understanding of applicable regulations of ASEAN Middle East and GCC Nations The associate will be responsible for working with multiple departments including Customer Service Sales Production and Engineering If you like wild growth and working with happy enthusiastic over-achievers you ll enjoy your career with us Not the right fit Let us know you re interested in a future opportunity by clicking Introduce Yourself in the top-right corner of the page or create an account to set up email alerts as new job postings become available that meet your interest

📌 Executive -regulatory Affairs (India)
🏢 Halma
📍 India