Avania · 1 month ago
Careers in our Regulatory Affairs Practice
United States
Full-time
Remote
Mid, Senior Level, Lead/Staff, Director/Executive
$80K/yr - $200K/yr
2+ years expAvania is the world's foremost global CRO built exclusively for medical technology, and they are seeking regulatory professionals at every level to build regulatory strategies that move markets. The role involves supporting or leading the development of regulatory strategies for medical devices and combination products, engaging with clients, and collaborating across various disciplines.
BiotechnologyHealthcareLife ScienceMedical DeviceClinical TrialsHealth Care
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
Qualification
Required
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
Preferred
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
Benefits
Annual bonus potential
Benefits
Company
Avania
Avania is the leading global MedTech-focused CRO, integrating regulatory strategy, clinical development, and market access with confidence.
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 & Chief Executive Officer
Angela Johnson
SVP Advisory Services
Recent News
2025-09-06
Business Wire India
2025-04-18
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