The RA specialist position will be responsible for:
- Direct , organize an coordinate RA &QA; activities in India & Neighbouring countries (India & SriLanka – mandatory regulatory , other countries: Bangladesh, Nepal, Maldives and Mauritius) sales organization to ensure business is conducted in compliance with regulatory, quality, safety , health and environment requirements required in each country
- Develop and improve RA&QA; standards and procedures to achieve organizational efficiencies and ensure optimal value to Business.

How You’ll Make an Impact:
Regulatory Affairs : 70%
- To ensure products are registered according to plan for India and neighbouring markets and maintain appropriate records for product compliance bodies (like CDSCO, MDR2017, IVD directives, CE, BIS ,electrical safety etc.)
- To maintain regulatory system update and data compliance on Veeva vault RIMS
- To ensure that necessary licenses and certifications are kept updated and renewed as per plan and timely circulations of licenses.
- Keeping up to date with company’s product range.




- Knowledge of SUGAM portal handling /CDSCOMDOnline.
- To coordinate and prepare submission of current, variations and renewal of registration, licenses and tracking.
- To assist customer notification including reports to authorities and manufacturing division and in the event of product quality problems, product recall and similar notification.
- To ensure product corrective action timely implemented.
- To maintain post market vigilance activities records & database (registration master database, customer product complaints, ICCR & product quality issue etc.)
- To ensure compliance to relevant environmental, health and safety regulations.
- To ensure compliance to code of conduct and business ethics codes.
- To maintain ERP product restriction due to regulatory requirements.
- To Support Tender submissions by providing Regulatory and Quality documents.
- To liaise with internal customer and division for any regulatory

📌 RA Spec II (Gurugram)
🏢 Bio Rad Laboratories
📍 Gurugram