Regulatory & Market Access Intern

Avania • Boston, MA • 20h ago

Avania are Hiring - Regulatory & Market Access Intern

About the Role

This is a broad, hands-on internship for someone who wants to see how a medical device actually gets to market. Over six months you will work with consultants on live client engagements spanning regulatory strategy, quality and compliance, clinical study design, and technical documentation. Consulting rewards people who can move between unfamiliar problems quickly, and this internship is built to find out whether that describes you.

The work touches a mix of software-only SaMD, embedded firmware in Class II/III devices, and traditional hardware devices. The clients range from a founder who has never spoken to FDA to seasoned regulatory teams who need an extra pair of hands to move a project forward.

We hire interns with the intention of converting them. This role is a working audition for a Consultant I position, and we will tell you throughout the term how you are tracking against that bar.

General Responsibilities

You will support consultants across the full range of Advisory Services work. In practice that means research and analysis feeding regulatory strategy - predicate searches, classification questions, competitor clearance analysis, guidance and standards review. It means drafting sections of client deliverables under consultant review: Pre-Submission packages, 510(k) sections, gap assessments, requirements and traceability documentation, study protocols and synopses. It means reading client documentation critically and flagging what is unsupported, vague, or inconsistent with what the product actually does, rather than summarizing what you are handed.

This is primarily internal, behind-the-scenes work. You will not be running client meetings, though you will sit in on internal strategy discussions and see how the work you produce gets used.

What We're Looking For

Currently enrolled in and graduating soon, or recently graduated from, a degree program in biomedical engineering, software engineering, computer science, electrical engineering, regulatory affairs, biostatistics, or a related technical or scientific discipline.

You do not need professional regulatory experience. You do need to arrive knowing what a 510(k) is, what a Design History File is for, and roughly what separates a Class I device from a Class III one - and to be able to explain in your own words why any of it exists.

You should be able to talk through a technical project you have worked on - coursework, co-op, research, or personal work - in enough depth to explain a decision you made and why you made it over the alternative. You should be able to read a short piece of technical or regulatory documentation and tell us where it is vague, unsupported, or internally inconsistent. We will ask you to do both.

Strong writing matters more here than almost anything else on this list. Nearly everything we deliver is written, and so is nearly everything FDA sees from us.

Proficient in Microsoft Office. Fluent in English, spoken and written.

Toronto or Boston preferred but not required. You must be able to travel to one of those offices a few times a year for training and team events, in the even that you are hired full-time.

Applicants must be legally authorized to work in the United States at the time of hire. This internship is intended to serve as a pathway to full-time employment. Candidates must have authorization to work in the United States that does not require current or future employer-sponsored visa sponsorship, as sponsorship is not available for this internship or subsequent full-time employment.

Avania - MedTech's Trusted Champion

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