Virtue America · 1 month ago
Regulatory Affairs Specialist
United States
Full-time
Remote
Mid Level
3+ years expVirtue America is seeking two Regulatory Affairs professionals with expertise in medical device submissions. The role involves working on PMA supplements and 510(k) applications, requiring strong knowledge of FDA regulations and submission strategies.
Information Technology & Services
Hiring Manager
Hema Kolluru
Responsibilities
Minimum 3 years of successful experience working on PMA supplements
Experience with original PMA submissions is preferred but not required
Strong knowledge of FDA PMA regulations, submission strategies, and lifecycle management
Minimum 3 years of recent experience preparing and submitting FDA 510(k) applications
Must have participated in at least one 510(k) submission using the FDA eSTAR format
Experience interacting with FDA CDRH is preferred
Exposure to the Division of Renal, Gastroenterology, Obesity, and Transplant Devices is a strong plus
Qualification
Required
Minimum 3 years of successful experience working on PMA supplements
Strong knowledge of FDA PMA regulations, submission strategies, and lifecycle management
Minimum 3 years of recent experience preparing and submitting FDA 510(k) applications
Must have participated in at least one 510(k) submission using the FDA eSTAR format
Bachelor's degree in a scientific, engineering, or related discipline
Strong understanding of FDA medical device regulatory pathways
Excellent documentation, communication, and project management skills
Preferred
Experience with original PMA submissions is preferred but not required
Experience interacting with FDA CDRH is preferred
Exposure to the Division of Renal, Gastroenterology, Obesity, and Transplant Devices is a strong plus
Company
Virtue America
We understand the everchanging needs of the staffing industry.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase