Careers in our Regulatory Affairs Practice

Avania
7d$80,000 - $200,000

About The Position

Avania is the world's foremost global CRO built exclusively for medical technology, and our Regulatory and Advisory Services team is where strategy meets science at full speed. We work with companies ranging from VC-backed startups racing toward their first FDA clearance to top-50 MedTech manufacturers navigating complex global submissions. Our clients come to us because we don't just know the regulations, we know how to turn regulatory strategy into competitive advantage. If regulatory strategy is what gets you out of bed in the morning, we are looking for you. We're hiring regulatory professionals at every level, from rising specialists sharpening their craft to senior experts who've been in the room with FDA and want to do it differently. If you're the kind of person who reads draft guidances for fun, who gets fired up about a well-architected predicate strategy, and who wants to work on technologies that really matter, keep reading.

Responsibilities

  • Building regulatory strategies that move markets. Depending on your level, you'll support or lead the development of 510(k), De Novo, PMA, CE Mark, and pre-submission strategies for medical devices and combination products. You won't be filling in templates. You'll be crafting regulatory narratives for technologies that don't fit neatly into existing pathways, because the most innovative ones never do.
  • Working across the globe. Our primary focus is FDA and EU MDR, but our reach extends to TGA, Health Canada, and beyond into 22+ countries. If you've got international regulatory chops (or want to build them), this is the place.
  • Sitting at the table with clients. You're not buried in a back office. You're on calls with CEOs, VP R&D leaders, and clinical teams, translating complex regulatory landscapes into actionable strategy. Clear, credible, commercially minded communication isn't optional here, it's the job.
  • Collaborating across disciplines. Our model integrates regulatory with clinical development, market access, R&D engineering, and AI/SaMD consulting. You'll work with biostatisticians, health economists, clinical operations leads, and engineering advisors. Silos don't exist here.
  • Contributing to something bigger. You'll participate in business development, thought leadership (white papers, publications, conference content), and the strategic growth of Advisory Services. This isn't a seat-filler role. You're helping build a business.
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