Regulatory Affairs Job at Aurolab | Pharmacy Graduates Apply Now
A medical device company is hiring a Regulatory Affairs Associate to support the development and global registration of their products. This Regulatory Affairs Job is perfect for a Bachelor’s degree in Pharmacy holder with 1–3 years of experience in a regulated industry. The associate will be critical in preparing submissions (like FDA 510(k) and CE mark Technical Files), maintaining compliance with EU MDR and ISO 13485, and ensuring the timely and safe market access for medical devices globally.
Job Post: Regulatory Affairs Associate
Location: Madurai
About the Company:
Aurolab is an integral, non-profit manufacturing division of the world-renowned Aravind Eye Care System, established in Madurai, India, in 1992 with the mission of eliminating needless blindness. The company was founded to address the prohibitively high cost of essential ophthalmic consumables, particularly Intraocular Lenses (IOLs), which were necessary for modern cataract surgery but inaccessible to millions in developing countries. By developing high-quality, internationally certified IOLs and pricing them at a fraction of the global market price (initially around $10), Aurolab acted as a global price catalyst, drastically increasing the accessibility of cataract surgery worldwide.
Pharmacy Job Summary
A Regulatory Affairs Associate in the medical device industry supports the development, registration, and compliance of medical devices throughout their lifecycle. This entry-to-mid-level role ensures products meet regulatory standards set by bodies such as the FDA (U.S.), EU MDR (Europe), and other international authorities. The associate works closely with cross-functional teams (e.g., R&D, Quality Assurance, Clinical, and Marketing) to prepare submissions, maintain documentation, and monitor regulatory changes, contributing to safe and timely market access for medical devices.
Key Responsibilities of the Pharmacy Job
- Assist in preparing, reviewing, and submitting regulatory documents, Technical Files/Dossiers for CE marking, and international registrations (e.g., for Canada, Australia, or emerging markets including 510(k) premarket notifications, Premarket Approval (PMA) applications).
- Support regulatory assessments for OBL’s product changes, labeling updates, and post-market activities, such as Medical Device Reporting (MDR), vigilance reporting, and field actions/recalls.
- Maintain and update regulatory databases, tracking submissions, approvals, and renewals on OBL products.
- Monitor and interpret evolving regulations (e.g., FDA guidance, EU MDR, ISO 13485, ISO 14971 for risk management) and communicate impacts to OBLs.
- Support post-market surveillance, including adverse event reporting and compliance with Unique Device Identification (UDI) requirements of OBL products.
Qualifications and Requirements
- Education: Bachelor’s degree in pharmacy.
- Experience: 1–3 years in regulatory affairs, preferably in medical devices (Class I–III), pharmaceuticals, or a related regulated industry.
Knowledge
- Familiarity with U.S. FDA regulations (21 CFR Parts 803, 820, 814), EU Medical Device Regulation (MDR 2017/745), MDSAP, and international standards (e.g., ISO 13485, ISO 14971).
- Understanding of medical device lifecycle, including design controls, clinical data requirements etc…
Skills
- Strong attention to detail and organizational abilities for managing complex documentation.
- Excellent written and verbal communication for preparing submissions and interacting with agencies.
- Analytical mindset to evaluate regulatory risks and changes.
- Ability to work in a fast-paced, team-oriented environment.
