Strongly reliable and focused Regulatory Affairs Specialist with great depth and breadth of experience in medical device
review and evaluation. Superb multitasker able to handle multiple projects efficiently and accurately. Effective
independent worker as well as excellent coordinator with other members of a regulatory affairs team.
06/2010 to Current
Regulatory Affairs SpecialistCarleton Science Solutions Inc - Waynesboro, PA
Developed regulatory strategies for new and modified radiological devices.
Provided guidance and feedback to regulatory affairs management.
Prepared and submitted internal regulatory file applications and supporting documentation.
Reviewed medical device labeling and advertising materials for accuracy and completeness.
Created and submitted state and federal licensing applications.
06/2006 to 05/2010
Regulatory Affairs SpecialistBaines Medical Testing Inc - Philadelphia, PA
Reviewed and responded to all product complaints and queries.
Provided applicable document for both domestic and international supply submissions.
Compiled and reviewed medical device registration data.
Ensured compliance with company state and federal requirements for all performed work.
Bachelor's Degree: BiotechnologyUniversity of Pennsylvania - Harrisburg, PABiotechnology Want more? Check out our other examples. See More Examples