Quality and Regulatory Filing Specialist for Medical Devices and Drug Products

at International Isotopes, Inc. in Idaho Falls, Idaho, United States

International Isotopes Inc. (INIS) and its fully owned subsidiary, RadQual LLC are Idaho Falls, Idaho based companies with a worldwide footprint. The INIS business model focuses on manufacture of Sodium Iodide I-131 solution drug for treatment of thyroid cancer, Class 1 radionuclide source medical device manufacture, and Co-60 teletherapy source manufacture.

Additional activities performed at INIS include topaz gemstone assay for release to the public, accepting returned Medical Devices, storage and disposal of radioactive waste, domestic and international shipping of radioactive materials, and associated support activities.

INIS holds certifications to ISO 9001 and 13485 standards and also works in compliance with cGMP FDA drug 21 CFR 210, 211 and medical device 21 CFR 820 regulations. We are also compliant to NRC, DOE, DOT, Health Canada, EUDAMED, UK Medical Device, and other regulations as applicable to our business model.

The successful candidate for the Quality and Regulatory Filing Specialistrole will:

• Track annual regulatory licensing/filings to ensure timely renewal for FDA, EUDAMED, UK MDR, etc.
• Maintain expert knowledge of applicable regulatory standards and guidance's as they update
• FDA filings, such as annual registration, annual reports, safety reports, 510K, ANDA revisions, etc.
• Assist management team with interpretation of requirements for import of Medical Devices and Drugs into foreign countries
• Support of Class I and II medical device history and master files
• Support of quality assurance tasks such as supplier evaluations, process and equipment validations, audits, etc.

  Primary Working Relationships

  • Reports directly to QA Manager, interacts with internal and external contacts, and operations personnel.