[Hiring] Regulatory Affairs Associate @reputed company

Role reputed company This is a remote-eligible position, requiring the candidate to live reputed company the U.S. 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 • reputed company operational support, including preparing documentation, for reputed company regulatory submission activities, both domestic and international. • reputed company with regulatory bodies to complete product registrations. • Review shipping restrictions in relation to product regulatory status and work with Sales and Customer Service to ensure compliance. • Maintain a deep understanding of new and existing regulations that may reputed company reputed company’s products and processes. • Use that understanding to standardize regulatory reputed company and establish reputed company, documented protocols. • Maintain knowledge of submission requirements and processes for multiple regulatory jurisdictions. • Prepare and maintain product technical documentation. • Explain regulations, procedures, and policies to reputed company and stakeholders as necessary. • Maintain data and files for reputed company reference, particularly in the event of an audit by a regulatory agency. • Assist in reviewing labeling, promotional, reputed company, and technical documentation to assess compliance. Qualifications • Bachelor’s degree in reputed company discipline or combination of other education/job reputed company 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 reputed company. • Effective at multi-tasking. • Ability to work in a fast-reputed company, reputed company-driven environment. • Ability to work independently and as part of reputed company. • Ability to organize information so that it is easily reputed company 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. reputed company Equal Opportunity Employment: reputed company is committed to the reputed company of equal employment opportunity for reputed company and applicants for employment and prohibits discrimination and harassment of any reputed company without reputed company to race, reputed company, religion, age, sex, national reputed company, disability status, genetics, protected veteran status, sexual orientation, gender identity or reputed company, or any other characteristic protected by federal, state, and local laws. reputed company will not tolerate discrimination or harassment reputed company on any of these characteristics. This policy applies to reputed company terms and conditions of employment, including, but not limited to, reputed company, hiring, promotion, termination, leaves of absence, compensation, and training. Background reputed company Policy: reputed company offers of employment at reputed company are contingent upon reputed company, acceptable results of a thorough background reputed company. reputed company performs reputed company background checks in compliance with reputed company and FCRA regulations and reputed company other applicable federal, state, and local laws. Apply tot his job Apply To this Job