Senior Consultant - Regulatory and Advisory Services

Avania; United States; On-site; USD 135,000 - 165,000; Full time

Benefits offered by this job

Bonus

Benefits

Job summary

Avania is hiring a Sr Consultant in Regulatory and Advisory Services to act as the primary regulatory expert for US FDA pathways. You will own key regulatory activities, deliver high-quality submissions (510(k), De Novo, PMA, pre-submissions) and work closely with global teams to align strategies with clinical development.

This role involves client interactions and shaping Avania's advisory offerings. The position focuses on cardiovascular and related therapeutic areas, with opportunities for

Qualifications

• Senior regulatory professional with medical device expertise.
• Experience with US FDA pathways (510(k), De Novo, PMA).
• Strategic regulatory guidance for complex device programs.

Responsibilities

• Serve as regulatory SME for US market and FDA pathways.
• Lead regulatory strategies and submissions (510(k), De Novo, PMA, pre-submissions).
• Collaborate with global regulatory, clinical and BD teams to align strategy with development plans.
• Manage multiple advisory projects and support business development activities.

Skills

Regulatory expertise

US FDA knowledge

Job description

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