The Regulatory Affairs Associate supports the preparation, formatting, review, and tracking of U.S. FDA regulatory materials to ensure they are accurate, complete, and submission-ready. This role works closely with senior regulatory leadership across active client engagements, maintaining documentation, performing detailed quality checks, and keeping submission workflows organized and on schedule.
This is an early-team role in a fast-paced startup environment. It begins with detailed document and formatting work and expands, as the client base grows and the individual demonstrates capability, into hands-on regulatory affairs work - submission strategy, guidance interpretation, and testing program support. How quickly the role expands depends on performance.
Responsibilities
· Support the preparation, formatting, quality control, and assembly of U.S. FDA regulatory submissions and technical documentation.
· Review dense scientific and regulatory documents in detail to identify errors, inconsistencies, and missing information.
· Cross-check materials against FDA guidance documents, recognized standards, and regulatory requirements.
· Manage submission documentation, references, and supporting files, maintaining version control throughout.
· Track submission status, deliverables, comments, and required follow-ups.
· Maintain organized records of regulatory submissions, correspondence, and project documentation.
· Support regulatory research and regulatory intelligence across a range of device categories.
· Help develop and maintain trackers, templates, and standard operating procedures.
· Monitor deadlines and communicate status updates to internal stakeholders.
· Adapt to shifting priorities and support multiple projects simultaneously.
Pay: ₹180,000.00 - ₹240,000.00 per year
Application Question(s):
- How many years of experience do you have in Medical Device Regulatory Affairs?
- Do you have experience with US FDA medical devices?
- Are you comfortable working from our Pune office?
- What is your current CTC and expected CTC?
- What is your notice period?
Work Location: Hybrid remote in Baner, Pune, Maharashtra
