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 – Sr Consultant - Regulatory and Advisory Services
Compensation
The approved base salary is up to $150,000, depending on experience, plus a 10% bonus, plus Benefits.
Avania may consider flexibility for a candidate whose expertise and experience exceeds the needs of the role
Avania is adding to our dynamic, multi-disciplinary Regulatory and Advisory Services team. We are seeking an experienced regulatory professional with expertise in medical device regulatory strategy, particularly with the U.S. FDA. This is a senior-consultant technical role for a regulatory SME who brings strategic insight, hands-on regulatory experience, and a proven ability to guide medical device companies through complex regulatory landscapes.
About the role
As a Sr Consultant within our Regulatory Affairs practice, you will serve as the primary regulatory expert for our clients, particularly focusing on the US market and FDA pathways. This role requires you to take ownership of key regulatory and advisory activities, including strategic input on 510(k), De Novo, PMA, and pre-submission pathways to market, supporting large and complex medical device programs with an emphasis on cardiovascular and other core Avania therapeutic areas. You will act as a subject matter expert (SME) and point of contact for clients, ensuring clear, credible, and commercially minded communication. Collaborating closely with global consulting, clinical, and business development teams, you will contribute to the successful delivery of high-impact regulatory strategies and client engagements. This position offers the opportunity to work in a dynamic, client-facing, and business-development–oriented environment, with a focus on shaping Avania's advisory offering and driving long-term growth of the business.
What you'll be doing
- Serve as a regulatory subject-matter expert for our global clients, particularly those targeting the US market and FDA pathways.
- Deliver high-quality regulatory strategies and submissions (e.g., 510(k), De Novo, PMA, pre-submissions and other path-to-market activities), drawing on deep former FDA experience.
- Collaborate closely with global consulting, clinical and regulatory teams to align regulatory strategy with clinical trial design and broader development plans.
- Oversee a diverse portfolio of advisory projects simultaneously, from a few high-touch, complex engagements to a broader mix of lighter-touch consultations, adapting involvement as needs ebb and flow.
Participate actively in business development and client-facing activities, including supporting BD in late-stage sales discussions, attending conferences, contributing to targeted LinkedIn outreach and thought leadership (e.g., white papers, speaking engagements), to help win new work and strengthen long-term client relationships
The ideal candidate will have prior experience working at the FDA. Experience working as a regulatory consultant or within a company developing a novel medical device is highly desirable.
What we're looking for
- Former FDA experience in medical devices, ideally including progression through roles such as reviewer, team lead, or division lead, with a preference for candidates who have operated at a senior level.
- Comfortable and skilled in client-facing roles, able to communicate effectively and serve as a trusted subject matter expert for our global clients on regulatory strategy and pathways to market.
- Ability to collaborate closely with cross-functional teams including clinical, regulatory affairs, consulting, and business development to ensure high-quality advisory and project deliverables.
- Experience or strong interest in device-related regulatory consulting, with cardiovascular, neurology, or orthopedics experience considered a significant advantage.
- Flexibility to manage multiple concurrent client engagements, ranging from deeply involved strategic projects to lighter-touch advisory support across a varied portfolio.
- Strong analytical skills to critically assess regulatory strategies and submissions (e.g., 510(k), De Novo, PMA, pre-submissions) and provide insightful, senior-level guidance to both clients and internal teams.
- Experience interacting with or supporting submissions to FDA centers such as CDER or CBER is an advantage
- Willingness to be actively involved in business development, including supporting sales cycles for both clinical trials and advisory services, engaging in thought leadership, and contributing to Avania's growth.
What you'll need
- Prior hands-on FDA experience, including roles within the Agency and exposure to major therapeutic areas such as cardiovascular, neurology, or orthopedics.
- Strong familiarity with US medical device regulatory pathways and requirements, including 510(k), De Novo, PMA, and pre-submission / pathway-to-market interactions.
- Excellent client-facing skills with the ability to communicate effectively and confidently with stakeholders, including sponsors, internal delivery teams, and senior leadership.
- Demonstrated track record of contributing to or leading business development activities (e.g., supporting sales cycles as an SME, helping close advisory and clinical projects, cultivating new client relationships).
- Ability to manage multiple parallel advisory and regulatory projects, flexing between deeply leading a few strategic engagements and providing oversight or ad hoc input on a broader portfolio.
- Comfortable working collaboratively with cross-functional teams, including clinical operations, regulatory affairs, commercial/BD, and other consulting colleagues in a global environment.
- Strong analytical and strategic skills, demonstrated through the ability to interpret complex regulatory and clinical issues, assess risk/benefit, and provide clear, actionable recommendations.
- Advanced scientific, clinical, or regulatory training (e.g., relevant degree and/or equivalent experience) that supports credibility as a senior subject matter expert with FDA and industry stakeholders.
- Prior consulting experience in a CRO or advisory setting is highly beneficial; comfort with thought leadership activities (e.g., conference speaking, white papers, LinkedIn presence) is a strong plus.
What we offer
We offer a dynamic and supportive work environment within a growing team focused on impactful regulatory and advisory projects for medical devices. You will have the opportunity to collaborate closely with cross-functional teams including clinical, regulatory, and commercial/business development, enhancing your professional development and market visibility. We provide a clear and structured interview process, competitive compensation, and the potential for career growth within our expanding global regulatory advisory group. Join us to shape pathway-to-market strategies, contribute to meaningful client engagements, and advance your expertise in a company committed to your success.
Avania - MedTech's trusted Champion
We look forward to receiving your application!
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.
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