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 quick-paced startup workplace. 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

📌 Regulatory Affairs Associate Baner
🏢 Tacticity Advisors
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