Regulatory Affairs Manager

Overview Join to apply for the Regulatory Affairs Manager role at Katalyst CRO. Location: Bellevue, WA. Compensation information provided in the original listing. Responsibilities Support and advise cross-functional teams and communicate APAC regulatory requirements and challenges effectively to meet project needs and company objectives. Oversee and direct the development of priorities, timelines, receipt of technical information from appropriate sources, and the preparation of regulatory documentation for new products, amendments of approved products, and submissions that support the maintenance of existing licenses. Support the implementation of policies, procedures, practices, and strategies to facilitate support of in-country product registrations in APAC. Work closely with the regional APAC regulatory team to develop and drive process efficiencies for APAC regulatory submissions. Review and evaluate issues that may create regulatory or business obstacles and propose solutions. Monitor APAC regulations/guidelines and the impact of changing/evolving regulations on submissions, practices, and procedures, and communicate to appropriate stakeholders. Manage the performance and career development of direct reports. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Requirements Bachelor's degree required, 5 years direct experience in Regulatory Affairs in a Medical Device Company required. Knowledge and Skill Requirements/Specialized Courses and/or Training. Strong interpersonal and communication skills. Proficient in Microsoft Office. Advanced written communication skills. Additional Information The listing includes standard statements about reasonable accommodations for applicants with disabilities and general workplace expectations. #J-18808-Ljbffr

Created: 2025-10-06