Role Overview

This is a senior individual-contributor role. You would own regulatory engagements from the first client conversation through to filing, working out the pathway, planning the evidence, writing the submission, and handling the correspondence when FDA comes back with questions.

Tacticity is a small practice, so the work is hands-on. There is no layer between you and the client, and no team of juniors to hand the drafting to. What you get in return is range, in a single quarter you might work on a Class II implant, an IVD and a piece of software-as-a-medical-device. You would also be the person a client calls when something goes sideways.

You would work closely with the founder, who spent his career reviewing these submissions from the other side of the desk at FDA. Expect your reasoning to be questioned, and expect to question back.

What You Would Be Doing

- Own the regulatory strategy on your engagements, classification and predicate analysis, pathway determination, and the evidence plan to support it.
- Lead 510(k), De Novo, PMA and Q-Submission preparation end to end, from outline to filing.
- Draft responses to Additional Information requests and deficiency letters, and help clients decide what to concede, what to argue, and what to test again.
- Run client meetings directly, including the difficult ones where the answer is not what the client wants to hear.
- Review test reports, biocompatibility evaluations and chemical characterisation data, and work out whether they actually support the claim being made.
- Review the work of Regulatory Affairs Associates, and contribute to scoping and proposals for new engagements.
- Assess software documentation on software-enabled and AI-enabled devices, lifecycle evidence, verification and validation, cybersecurity and usability files, and judge whether it will withstand reviewer scrutiny.

What We Are Looking For





- Three to five years of hands-on regulatory affairs experience in medical devices, IVDs or SaMD. Consulting, CRO and in-house manufacturer backgrounds are all welcome.
- At least one FDA submission you owned end to end on your own, from a blank page through to filing, without a team drafting around you. Software and SaMD submissions carry the most weight with us. We will ask about it in detail: the pathway, what you argued, and what FDA came back with.
- A Bachelor's, Master's, PharmD, MTech or PhD in Life Sciences, Biomedical Engineering, Biotechnology, Pharmacy, Engineering or a related field.
- Working knowledge of 21 CFR Parts 807, 814 and 820, ISO 13485 and ISO 10993, together with a strong command of the software standards — IEC 62304 software lifecycle documentation, IEC 62366-1 usability engineering, and ISO 14971 risk management as it applies to software hazards.
- Substantive experience with SaMD and software-enabled devices, software requirements and architecture, V&V; evidence, SOUP documentation and requirements-to-hazard traceability.
- Familiarity with FDA premarket cybersecurity expectations, threat modelling, SBOM generation and vulnerability assessment.
- Comfort in regulatory and engineering systems, traceability tools such as IBM DOORS Next or Jira, submission publishing and validation software, and document or quality management platforms.
- Writing a reviewer can follow without effort, a submission is an argument, and a badly written one loses.
- The judgement to say when a question is outside your experience rather than guessing. A confident wrong answer is expensive in this work.

Useful,



But Not Essential

Direct correspondence with FDA reviewers; work on AI or machine-learning enabled devices; exposure to EU MDR alongside FDA; or experience of a submission that did not go well, and a clear view of why.

What This Role Is Not

Worth being straightforward, because the fit matters more than the CV. This is not a large-company role with a narrow scope, you may be doing strategy in the morning and formatting a submission table in the afternoon. It is not a quality or QMS role. And it is not initially a people-management role: you would mentor associates rather than have a team from day one, though it is expected to grow into leading the regulatory team as the practice expands.

Location

This position can be hybrid (office – Baner, Pune) or fully remote, and full time or part-time, depending on the candidate. We would rather have the right person remotely than the wrong person in the room.

Worth being open about one thing: the fastest growth sits in Pune — more client meetings in person, more time with the founder, and a shorter path to taking on the team. Remote works well for the submission work, but limits that exposure.

How to Apply

Interested candidates should email their resume/CV to:

[email protected]

Subject line: Application – Regulatory Affairs Manager / Consultant In the body, please summarise your experience and the device categories you have worked on; describe one submission you owned, setting out the regulatory question, what you decided and what you would do differently now; and say why this role interests you.

Written communication is central to this role, so the email forms part of the assessment. We would rather read three thoughtful paragraphs than a polished cover letter that could have been sent to anyone.

Pay: From ₹510,000.00 per year

Work Location: Hybrid remote in Pune, Maharashtra 410001

📌 Regulatory Affairs Manager / Consultant (Pune)
🏢 Tacticity Advisors
📍 Pune