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Job Type
Full-time
Description
- This is a remote-eligible position, requiring the candidate live within the U.S.
Job Purpose
The Regulatory Affairs Associate/Specialist is primarily responsible for preparing IVD regulatory documents for submission to various regulatory agencies, both domestic and international
Key duties and 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
Qualifications
Required:
- 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
Equal Opportunity Employment: IMMY is committed to the principle of equal employment opportunity for all employees and applicants for employment and prohibits discrimination and harassment of any kind without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, and local laws. IMMY will not tolerate discrimination or harassment based on any of these characteristics. This policy applies to all terms and conditions of employment, including, but not limited to, recruiting, hiring, promotion, termination, leaves of absence, compensation, and training.
Background Check Policy: All offers of employment at IMMY are contingent upon clear, acceptable results of a thorough background check. IMMY performs all background checks in compliance with EEOC and FCRA regulations and all other applicable federal, state, and local laws.