Regulatory Affairs Specialist Resume Examples

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.

• Extensive experience in quality assurance and regulatory affairs work environments
• Superior expertise in medical device regulations and reporting
• Excellent proficiency with software tools and metrics
• Strong knowledge of radiation testing practices and principles
• High skills in maintaining professional relationships with all levels of staff
• Outstanding analytical and problem-solving abilities

• Develop regulatory strategies for new and modified radiological devices.
• Provide guidance and feedback to regulatory affairs management.
• Prepare and submit internal regulatory file applications and supporting documentation.
• Review medical device labeling and advertising materials for accuracy and completeness.
• Create and submit state and federal licensing applications.

• Reviewed and responded to all product complaints and queries.
• Provided applicable documents 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.