Regulatory executive

6 days ago


New Delhi, India eTeam Full time

Education & Qualifications Required : Bachelor’s degree in Life Sciences, Pharmacy, Biomedical Engineering, or related field. Preferred : Master’s degree in a scientific discipline (Pharma, Biology, Microbiology, Chemistry). Experience Internship or ~1 year of experience in regulatory affairs in medical devices/pharma Fresh graduates with strong academic background and interest in regulatory affairs may apply. Job Summary : The Regulatory Executive will support the regulatory affairs team in ensuring compliance with Indian and international medical device regulations. This role involves assisting in product registrations, renewals, database management, documentation, labelling and communication with regulatory authoritiesfor Greater India region across all Business Units. Key Responsibilities : Assist in preparing and submitting regulatory documents for product registrations, renewals, and variations. Maintain regulatory records and trackers accurately in internal systems in co-ordination with RA team. Support labeling reviews and ensure compliance with applicable regulations. Coordinate with internal teams (Quality, Marketing, supply chain) for regulatory inputs. Monitor updates in Indian medical device regulations and assist in implementing changes. Prepare basic reports and summaries for internal and external submissions. Implement other internal regulatory compliance processes and contribute to the process improvement. Contribute in the follow-up meetings and conferences with regulatory authorities to remain up to date with regulation changes and industry trends. Other incidental duties: provide regulatory support to other relevant local or global cross-functional projects Additional Skills : Good written and verbal communication skills Basic knowledge of India Medical Device Rules in India and neighbouring markets.



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