FDA Regulatory Strategy Lead - Medical Devices

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 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