Regulatory Affairs Manager

About FreyrFreyr is a fast-growing, innovative company specializing in providing end-to-end regulatory solutions and services for the Life Sciences industry. With a commitment to excellence and innovation, we assist pharmaceutical, medical device, and biotech companies in navigating the complexities of regulatory compliance.Why Freyr?At Freyr, we believe in fostering a collaborative and dynamic work environment that empowers our team to make a real impact. As we expand our footprint to Warsaw, Poland, we are on the lookout for passionate and skilled Regulatory professionals to join us in shaping the future of regulatory services.Join Our Team:If you're ready to embark on a journey of growth and innovation, connect with us to explore the exciting opportunities awaiting you at Freyr. Together, we can shape the future of regulatory solutions.📢 To Apply:Please apply to this job post or you can visit our Careers page for more openingsVisit our Careers page at (https://www.freyrsolutions.com/careers/current-positions) to explore current job openings and submit your application.Don't miss this chance to be a part of Freyr's expansion and make your mark in the world of regulatory services. Let's redefine regulatory excellence together!Title : Regulatory Affairs Manager / ConsultantLocation : South KoreaKey Skills : Regulatory Affairs, QMRPrimary ResponsibilitiesQMR & Quality Management System (QMS) Responsibilities:Act as the designated Quality Management Representative (QMR) for Freyr’s importation license in South Korea.Establish, implement, maintain, and continuously improve a single, unified Quality Management System (QMS) compliant with Korean medical device standards, covering all products imported from manufacturers.Develop and maintain all Standard Operating Procedures (SOPs) for the QMS, including processes for receiving, storage, inspection, and release of all client products.Oversee all necessary testing and inspections of imported medical devices as required by the QMS and regulatory standards.Create, review, and maintain all manufacturing and quality control records for each imported product batch.Perform the final evaluation of quality management results to formally authorize the shipment and release of all products into the Korean market.Ensure all Freyr-managed facilities and storage areas are maintained in a sanitary condition to prevent contamination and manage any hazardous materials in the workplace.Oversee the hygiene of all employees involved in the process and provide necessary training on the QMS; monitor the completion and effectiveness of this training.Importer & Local Representative (LR) Service Responsibilities: Manage the end-to-end importation process for all client products under Freyr’s license, ensuring all documentation and procedural requirements are met.Liaise with appointed customs agents to ensure smooth physical importation and clearance, while retaining overall responsibility for regulatory compliance under Freyr's QMS.Handle all post-market surveillance activities, including adverse event reporting and managing any necessary recalls or safety actions in compliance with Korean regulations.Review quality of investigation and create vigilance reportsRegulatory Service Responsibilities:Product Registration and Licensing: Preparation, submission, and maintenance of regulatory submissions to the South Korean regulatory authoritiesSupporting in planning and implementing the regulatory strategy for medical devices/IVD’s/SaMD’s/Combination products(if applicable) registration activities for clients.Responsible for planning, executing, and coordinating all regulatory activities including all change managements, providing all possible supports for customer’s market expansion activities.Able to manage the end-to-end process of registration of Medical Devices/IVDs/SaMD’s/Combination products(if applicable) with various internal departments, external consultants as well as HAs, and to provide/coordinate guidance and insights throughout the process.Secondary ResponsibilitiesParticipate in internal team, organization, and division-level meetings and training initiatives.Monitor and analyze regulatory trends and industry developments in South Korea to provide strategic insights to the organization and its clients.Support cross-functional teams (e.g., Marketing, Sales, Business Leadership) as a subject matter expert on South Korean quality and regulatory requirements.Key Performance IndicatorsMaintenance of a single, compliant, and audit-ready Quality Management System for Freyr's importation business, successfully passing all internal and external audits.Successful and timely completion of client projects while maintaining high-quality deliverables and client satisfaction.Effective management of importer and local representative duties.Competency development for the service line and positive client feedback.Qualifications and ExperienceQualifications:Must meet at least one of the following criteria.A Bachelor's degree or higher from an accredited university in Medical sciences, healthcare management Engineering or equivalent A license in a specialized field, such as an Optician, Dental Technician, Dental Hygienist, Radiologic Technologist, or Physical Therapist, if managing related medical devices.A national technical certification as a Medical Engineering Technician or Quality Management Technician.A professional certification as a Medical Device Regulatory Affairs (RA) Expert.A Bachelor's degree in a non-related field combined with a Master's degree (or higher) in a relevant medical device field.A combination of a degree/diploma and specific work experience in medical device quality management (typically 1-5 years, depending on the level and relevance of the education).Extensive experience (6+ years) in quality management within a medical device manufacturing or import company.Experience in Complaints handling processes and Vigilence Reporting. Experience:Demonstrable experience in medical device quality management and/or regulatory affairs, with the number of years.Proven experience in establishing and maintaining a Quality Management System (QMS).Experience interacting with the MFDS and managing regulatory submissions is highly preferred.Language and Other Requirements:Fluency in Korean and English (both written and spoken) is required.Must be legally eligible to work in South Korea.