Regulatory Affairs Associate

Regulatory Affairs Associate/SpecialistThe 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 include:Providing operational support, including preparing documentation, for all regulatory submission activities, both domestic and internationalInteracting with regulatory bodies to complete product registrationsReviewing shipping restrictions in relation to product regulatory status and working with Sales and Customer Service to ensure complianceMaintaining a deep understanding of new and existing regulations that may impact IMMY's products and processesUsing that understanding to standardize regulatory operations and establish clear, documented protocolsMaintaining knowledge of submission requirements and processes for multiple regulatory jurisdictionsPreparing and maintaining product technical documentationExplaining regulations, procedures, and policies to all employees and stakeholders as necessaryMaintaining data and files for future reference, particularly in the event of an audit by a regulatory agencyAssisting in reviewing labeling, promotional, legal, and technical documentation to assess complianceQualifications include:Bachelor's degree in related discipline or combination of other education/job related experience; 2+ years of Regulatory Affairs job experience required for Specialist categorizationEffective technical writing and oral communication skillsExtremely organized with high attention to detailEffective at multi-taskingAbility to work in a fast-paced, timeline-driven environmentAbility to work independently and as part of a teamAbility to organize information so that it is easily understood and reviewed, both internally and externallyAbility to identify ways to improve/simplify processesFamiliarity with FDA, IVDD, IVDR, ISO 13485, GMP and other major international regulatory requirementsAbility to read and interpret IVD domestic and international regulationsExperience in a regulated environment, preferably in Medical Devices or IVDsExperience with regulatory submissions, preferably in Medical Devices or IVDsEqual 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.