Avania · 6 hours ago
Vice President, Regulatory and Advisory Services
United States
Full-time
Remote
Director/ExecutiveAvania Clinical is a leading contract research organization (CRO) that offers exciting career opportunities for professionals in the clinical research industry. The Vice President of Regulatory and Advisory Services will serve as the primary regulatory expert for clients, focusing on U.S. FDA pathways and leading high-quality regulatory strategies and submissions for medical devices.
Health CareMedical Device
Responsibilities
Serve as a senior regulatory subject-matter expert for our global clients, particularly those targeting the US market and FDA pathways
Lead and 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
Qualification
Required
Significant, hands-on FDA experience (minimum of several years), ideally including leadership roles within the Agency (e.g., division or team lead) 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
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/principal or VP-equivalent 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
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
Preferred
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
Benefits
Competitive compensation
Potential for career growth
Company
Avania
Avania is a full-service contract research organization focused on the management of clinical studies for medical devices, IVDs, biologics.
Founded in 1988
201-500 employees
Funding
Current Stage
Growth StageTotal Funding
unknownKey Investors
Kester Capital
2022-06-20Acquired
2016-06-01Private Equity
Leadership Team
Jason Monteleone
President and CEO
Angela Johnson
SVP Advisory Services
Recent News
2025-09-06
Business Wire India
2025-04-18
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