Tacticity Advisors is a regulatory science practice helping medical device, IVD, and SaMD companies navigate U.S. FDA, founded by Dr. Tanmay Jain, PhD, a former FDA CDRH scientist and lead reviewer. We are looking for a Regulatory Affairs Associate to work directly on real client submissions, learning the discipline from someone who has reviewed it from inside the agency.

This is not a role where you shadow from the sidelines. You will work on actual 510(k) strategies, biocompatibility evaluations, and FDA deficiency responses from day one, with direct mentorship from a founder who spent years on the review side of FDA.

1) Key Responsibilities:-

- Support the preparation of 510(k), De Novo, and PMA submissions, including pathway analysis and predicate research
- Assist in developing biocompatibility strategies and chemical characterization assessments aligned to ISO 10993
- Research FDA guidance documents, recognized standards, and relevant precedent decisions to inform client strategy
- Draft and review technical documentation, gap assessments, and regulatory correspondence
- Support clients through FDA deficiency letters, Form 483 responses, and Warning Letter remediation
- Track evolving FDA requirements, including QMSR and ISO 13485 transition guidance, and translate them into practical client recommendations

2) What We're Looking For:-





- 2–4 years of experience in U.S. FDA medical device regulatory affairs, required
- A background in life sciences, biomedical engineering, pharmacy, or a related technical field
- Working familiarity with 510(k), De Novo, or PMA submission processes and FDA guidance documents
- Strong written communication skills, comfortable producing clear, exact regulatory documentation
- Detail-oriented, comfortable working with FDA guidance documents, standards, and technical literature
- Able to manage multiple client workstreams in a fast-paced, high-ownership environment

3) Why This Role:-

- Direct, hands-on mentorship from a former FDA CDRH lead reviewer, sharpening judgment you've already started building, not starting from zero
- Real exposure to submissions across 510(k), biocompatibility, and enforcement response, not a single narrow function
- A front-row seat to how U.S. FDA regulatory strategy actually gets built, and why it works or fails
- Meaningful ownership early, client-facing regulatory work, not years of internal-only tasks before real responsibility

Pay: ₹300,000.00 - ₹800,000.00 per year

Benefits

- Flexible schedule

Experience:
- US FDA Medical Device Regulatory: 1 year (Preferred)

Work Location: Hybrid remote in Baner, Pune, Maharashtra

📌 Regulatory Affairs Associate (Baner)
🏢 Tacticity Advisors
📍 Baner