Regulatory Affairs Associate
IMMY•Norman, OK
•Remote
About The Position
The Regulatory Affairs Associate/Specialist is primarily responsible for preparing IVD regulatory documents for submission to various regulatory agencies, both domestic and international. This is a remote-eligible position, requiring the candidate live within the U.S.
Requirements
- Bachelor’s degree in related discipline or combination of other education/job related experience
- 2+ years of Regulatory Affairs job experience required for Specialist categorization
- Effective technical writing and oral communication skills
- Extremely organized with high attention to detail
- Effective at multi-tasking
- Ability to work in a fast-paced, timeline-driven environment
- Ability to work independently and as part of a team
- Ability to organize information so that it is easily understood and reviewed, both internally and externally
- Ability to identify ways to improve/simplify processes
- Familiarity with FDA, IVDD, IVDR, ISO 13485, GMP and other major international regulatory requirements
- Ability to read and interpret IVD domestic and international regulations
- Experience in a regulated environment, preferably in Medical Devices or IVDs
- Experience with regulatory submissions, preferably in Medical Devices or IVDs
Responsibilities
- Provide operational support, including preparing documentation, for all regulatory submission activities, both domestic and international
- Interact with regulatory bodies to complete product registrations
- Reviewing shipping restrictions in relation to product regulatory status and work with Sales and Customer Service to ensure compliance
- Maintaining a deep understanding of new and existing regulations that may impact IMMY’s products and processes
- Using that understanding to standardize regulatory operations and establish clear, documented protocols
- Maintaining knowledge of submission requirements and processes for multiple regulatory jurisdictions
- Preparing and maintaining product technical documentation
- Explaining regulations, procedures, and policies to all employees and stakeholders as necessary
- Maintaining data and files for future reference, particularly in the event of an audit by a regulatory agency
- Assist in reviewing labeling, promotional, legal, and technical documentation to assess compliance
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
