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 workplace 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