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Regulatory Affairs Specialist

at Immuno-Mycologics Inc. in Norman, Oklahoma, United States

Job Description

Job purpose 

The Regulatory Affairs Specialist is primarily responsible for preparing IVD regulatory documents for submission to various regulatory agencies, both domestic and international 

Key duties and responsibilities

Key responsibilities for the Regulatory Affairs Specialist include:

· Timely preparation of documents for regulatory submissions

· 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

Qualifications

Qualifications include:

· Bachelor’s degree in science or combination of other education/job related experience

· 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

· Familiarity with FDA, IVDD, IVDR, ISO 13485, and GMP

· Ability to read and interpret IVD domestic and international regulations

· Experience in a regulated environment, preferably in Medical Devices

· Experience with regulatory submissions, preferably in Medical Devices

 

 EEO/M/F/Disabled/Vets  

Job Details

Company

Immuno-Mycologics Inc.

Location

2701 Corporate Centre Drive
Norman, Oklahoma 73069
United States

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Job Posting: 2056950

Posted On: May 19, 2021

Updated On: Jun 30, 2021