Global manufacturer in need of an experience Regulatory Affairs consultant to support the preparation, coordination, documentation and regulatory submittal process of Medical Device Licenses into multiple markets. The ideal candidate would have experience with FDA law and familiar with the analysis of data and literature in support of regulatory submissions.
location: Gainesville, Florida
job type: Contract
salary: $65 - 75 per hour
work hours: 8am to 5pm
- Prepare all related documents in the product Development Life Cycle
- Advise effective ways to successfully obtain approvals of regulatory applications for the business
- Oversee global compliance on product registrations, clinical evaluations Medical Device Regulations, etc.
- Responsible for updating the Technical Files for multiple markets (Canada, US & Europe)
- Bachelor's degree in public health, Healthcare administration or related field
- 5 years Imaging Diagnostic or medical device industry
- Regulatory Affairs Certification
- ISO 14155 and EU MDR
- 510(k) submissions
- International registration of medical devices
- Knowledge of regulations (21CFR), FDA law, MDD
- US Device Listings
- GUDID (UDI)
100% remote role
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.