Avania is the only global CRO built for MedTech — integrating regulatory strategy, clinical development, and market access and reimbursement to take innovations from concept to commercialization with confidence. Avania was purpose-designed to serve medical technology innovators, combining regulatory, clinical, engineering, and market access expertise to guide products across the full lifecycle
Join our team of subject matter experts and contribute to the development of life-changing medical devices that improve patients' lives worldwide.
Avania - MedTech's trusted Champion
Avania are hiring - Consultant II / Senior Consultant – Advisory Services (Clinical Strategy & Evidence Generation) | Canada or US
Salary range $100,000 to $150,000 DOE, rank, and Location + 10% annual performance related bonus + benefits
About Avania
Avania Clinical is the world's only global CRO exclusively focused on medical technology, serving 90% of the top 50 MedTech companies across eight offices on three continents.
Our Advisory Services division provides premium consulting across regulatory strategy, quality and compliance, R&D engineering, and AI/SaMD guidance. We work with everyone from Series A startups bringing their first device to market to Fortune 500 MedTech leaders launching next-generation AI-enabled platforms.
About the Role
This is a role for someone who has designed and been a part of executing clinical studies. You will sit across from a client's clinical and regulatory team, look at the evidence they have and the claims they want to make, and be able to tell the difference between a study that will satisfy an FDA reviewer and one that will generate a deficiency letter. You will then help them bridge those gaps and take that study design to FDA in a presubmission meeting, negotiating the details of the protocol. When clients come to us later (i.e. after already submitting their 510(k), De Novo or PMA), you will build the argument that defends their existing evidence: data analysis strategy, literature review, and where necessary a proposal for the additional study that closes the gap.
Most of the studies we work on are experimental -- sham-controlled randomized trials and device accuracy/validation studies (i.e. comparing data from a novel device to "ground truth"), though we also work on single-arm studies for pre-market approval and post-market surveillance (i.e. observational or retrospective with a single arm benchmark comparison or matched comparator).
We work on software as a medical device including digital therapeutics, IVDs (especially on the software that interprets diagnostic tests), and a steady stream of AI-enabled therapeutic and diagnostic products, though we also work on many other device types in neurology, cardiology, aesthetics. Comfort moving between very different clinical contexts matters more than deep expertise in any single therapeutic area.
Level of prior experience required is dependent on rank. This role reports directly to the VP of Regulatory & Compliance Services, who currently leads the clinical research advisory practice.
General Responsibilities
This role goes beyond summarizing what you are told in a protocol or filling in a template — it's strategic. You will work through a client's clinical evidence at a level of detail that lets you catch where an endpoint will not support the claim, where a control arm will not hold up, where a sham fails to adequately control for expectancy effects, or where a statistical analysis plan isn't written in FDA's "language." You will turn that review into presubmission packages, study designs, protocol input, clinical evidence summaries, and deficiency responses built to survive an FDA reviewer's scrutiny.
You will also be trained on the wider regulatory work this team delivers, including 510(k) and De Novo submissions and their supporting documentation, and supported in earning the certifications that go with it. We expect you to arrive with a solid clinical research foundation and to build the regulatory layer on top of it here. The level of training you'll be provided, and the level of initial client management responsibility expected of you right away, is dependent on your level of experience and rank (see below).
Candidates who offer any combination of the skills, knowledge and experience listed below, are encouraged to apply for the role, and to use the criteria in this ad to declare which rank is commensurate with their experience.
What We're Looking For
Degree in a clinical, life sciences, or quantitative discipline. Clinical research, biostatistics, psychology (with a clinical/RCT emphasis), neuroscience, biomedical engineering, or a related field. Advanced degrees are welcome but not required if the hands-on experience is there.
Direct experience designing, running, and/or analyzing randomized-controlled designs in clinical populations, ideally under GCPs. Randomized and sham or sham-equivalent controlled work is what we do most, so that is what we weight most heavily. While we do not write IRB applications, experience writing them is a helpful indicator of familiarity with the details of study design that applicants should emphasize if they have it.
Senior Consultant is generally suited to candidates with one to three years of regulatory consulting experience and demonstrated client management skills. A Senior Consultant has worked in or around regulated clinical research/medical device environments enough to know what a presubmission, an IDE, a 510(k), and a clinical evidence deficiency actually mean in real-world practice. Senior Consultant Candidates should be able to look at a study design and say specifically where FDA would push back and why.
Consultant II is suited to candidates with strong clinical research fundamentals who are ready to build regulatory expertise and client-facing experience. A Consultant II candidate should also be able to talk through a trial you personally worked on, in enough depth to explain a design decision you made and the tradeoff you accepted in making it.
There is substantial room to grow in this role, either as an individual contributor or a practice lead.
Proficient in Microsoft Office. Fluent in English, spoken and written, with strong scientific writing skills.
Ability to report to Boston in person as required for training, client work, and/or team events.
Applicants must be legally authorized to work in the United States or Canada at the time of hire. Candidates must have authorization to work in the United States or Canada that does not require current or future employer-sponsored visa sponsorship, as sponsorship is not available for this role.
Avania - MedTech's trusted Champion
Avania takes pride in being an equal opportunity employer. We consider qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status, or any other legally protected characteristic.
#LI-DNI