Careers in our Regulatory Affairs Practice at Avania · United States · Joined
A
Careers in our Regulatory Affairs Practice
Avania · United States · Just now · 0 applicants
NewOn-siteFull-timeLead
Pay
$80k–$200kListed
Workplace
On-site
Job type
Full-time
Level
Lead
Team: Regulatory Affairs Practice · Source: jobright · Posted by joined-scrapper
About the role
Regulatory professionals at Avania Advisory Services develop and lead regulatory strategies for medical devices and combination products, advising clients on US, EU, and international submissions while collaborating across clinical, engineering, and market-access disciplines.
What you’ll do
Develop and lead regulatory strategies for medical devices and combination products
Advise clients on US, EU, and international submissions and pathways
Collaborate across clinical, engineering, and market-access disciplines
Contribute to business development and thought leadership
Manage multiple clients and translate regulations into actionable guidance
Support clinical evidence frameworks from usability studies to pivotal trials and real-world evidence
What you’ll need
Direct experience with medical device regulatory affairs, submissions, strategy, compliance, or engineering
Knowledge of FDA submission types (510(k), De Novo, PMA, Pre-Subs)
Experience with EU MDR/IVDR technical documentation
Design controls and risk management skills (ISO 14971, IEC 62304, IEC 62366)
Familiarity with quality management systems and nonclinical testing strategies
Strong interest or experience in cardiovascular, neurology, orthopedics, or emerging technology areas
Original job description
Avania Advisory Services is hiring regulatory professionals to develop and lead regulatory strategies for medical devices and combination products. The role advises clients on US, EU, and international submissions and pathways, collaborates across clinical, engineering, and market-access disciplines, and contributes to business development and thought…