Regulatory Affairs Associate

Immy; Norman, Northern (OK, KY); On-site; USD 70,000 - 105,000; Full time

Job summary

IMMY seeks a Regulatory Affairs Associate/Specialist to prepare regulatory documents for domestic and international submissions for in vitro diagnostics. This remote-eligible role requires you to live in the United States.

You will support submissions, interact with regulatory bodies, maintain technical documentation, and help ensure labeling and promotional materials comply with FDA, IVDD/IVDR, ISO 13485, and GMP standards. Strong writing and organization are essential.

Qualifications

• Bachelor’s degree in a related discipline; 2+ years of Regulatory Affairs experience for Specialist.
• Strong technical writing and clear oral communication.
• Highly organized with strong attention to detail.
• Ability to work in a fast-paced, timeline-driven environment.
• Experience with FDA and international regulatory requirements.

Responsibilities

• Prepare regulatory submissions for domestic and international markets.
• Interact with regulatory bodies to complete product registrations.
• Ensure compliance by reviewing labeling, shipping, and promotional docs.
• Maintain product technical documentation and audit-ready files.
• Translate regulations into clear internal processes and policies.
• Stay current with FDA, IVDD, IVDR, ISO 13485, GMP requirements.
• Explain regulations to employees and stakeholders as needed.

Skills

Technical writing

Regulatory knowledge

Oral communication

Attention to detail

Organizational skills

Multi-tasking

Independent worker

Team collaboration

FDA familiarity

IVDR/IVDD knowledge

Education

Bachelor’s degree in related discipline

Job description

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 processesFamiliarity 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.