Regulatory Specialist (Open Rank - Associate/Principal/VP), US/EU/Global Focus 

Avania Advisory Services

Salary range across multiple level roles $80,000 - $200,000 +/- DOE with Annual bonus potential + Benefits

We don't do checkbox regulatory. We do the MedTech work that changes medicine. 

Right now, somewhere in our pipeline, there's a first-in-class neurostimulation device that could transform how we treat patients. A cardiovascular implant that cardiologists are calling a paradigm shift. A combo product coated with multiple active nanomaterials. An AI-powered diagnostic that's about to redefine how radiologists read scans. And a Software as Medical Device platform that needs a regulatory strategy no one has written yet, because the FDA guidance is still in draft. 

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. 

What You'll Actually Be Doing 

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. 

What Makes This Different 

The technology. Our clients are building the devices and platforms that will define the next decade of medicine. Neurotech. AI-enabled diagnostics. Next-generation cardiac implants. Interventional oncology systems. Software that learns and adapts. If it's pushing the boundary of what's possible, it's probably on our desk. 

The model. We're not a legacy CRO bolting on a consulting arm. We're building a fundamentally different advisory model, one that integrates regulatory strategy, clinical development, market access, R&D engineering, and AI/SaMD expertise under one roof. You'll be part of shaping that model, not just operating within it. 

The pace. This is not a 9-to-5 regulatory affairs job. We move fast, we think big, and we expect excellence. If you thrive on energy, love solving problems nobody's solved before, and want to grow faster than you thought possible, you'll feel at home. 

The team. We've assembled a regulatory dream team, former FDA reviewers, seasoned industry strategists, AI regulatory specialists, market access experts. You'll learn from the best and collaborate with people who are genuinely passionate about what they do. 

The trajectory. We offer a real career path with structured development, competitive compensation, and the kind of visibility that comes from working at the intersection of innovation and regulation. Senior roles include travel opportunities and direct client leadership. 

The Bottom Line 

We are MedTech’s champions. We show up for the companies building technologies that save lives, restore function, and push the boundaries of human health. We need people who feel that in their bones, not just on their resume. 

If you're ready to do the most meaningful regulatory work of your career, in the most dynamic environment in MedTech, we want to hear from you. 

What We're Looking For 

The science-and-strategy guru. You love the technical depth of regulatory submissions AND the strategic chess of pathway selection. You can go deep on a risk analysis and then zoom out to explain the business implications to a board. 

Hands-on regulatory experience. Whether it's two years or twenty, you've worked directly with medical device regulatory affairs, submissions, strategy, compliance, or engineering relevant to devices. CRO, consultancy, or manufacturer experience all count. 

Technical fluency. You know your way around: 

• FDA submission types (510(k), De Novo, PMA, Pre-Subs) 
• EU MDR/IVDR Technical Documentation 
• Design controls and risk management (ISO 14971, IEC 62304, IEC 62366) 
• Digital health regulatory landscape (AI/ML, SaMD/SiMD, CDS, cybersecurity) 
• Quality management systems (ISO 13485, 21 CFR Part 820/QMSR) 
• Nonclinical testing strategy (ISO 10993 series, IEC 60601) 
• Clinical evidence frameworks, from usability studies to pivotal trials to RWE 

A consulting mindset. You thrive on variety, can manage multiple clients simultaneously, and know how to read a room. You translate regulations into advice people can actually use. 

Therapeutic passion. Strong interest or experience in cardiovascular, neurology, orthopedics, or emerging technology areas (neuromodulation, AI diagnostics, interventional oncology) is a significant advantage. We work on the frontier, and we need people who want to be there. 

A growth engine. You don't just execute,  you improve, you build, you push. You have a drive to learn, to lead, and to leave things better than you found them. 

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. 

We look forward to receiving your application!

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