Company:
Korean subsidiary of international corporation, market leader in the design, manufacture, supply and support of reagents and instrumentation in the in-vitro diagnostics field.
Position Description:
Responsible for developing regulatory strategies and interacting with regulatory bodies.
Responsible for processing the registration of new products with the Korean Ministry of Food Drugs and Safety (MFDS) and carrying out the appropriate amendments when necessary.
Responsible for defining and coordinating the company Quality System and continuously monitor its operation to ensure ongoing compliance.
Position Responsibilities:
¡¤ Define the regulatory strategy and manage regulatory submission activities for new product development activities and product maintenance for existing approved products.
¡¤ Work with regulatory affairs specialists, engineers and technical experts from manufacturing to resolve potential regulatory issues and questions from regulatory agencies.
¡¤ Prepare MFDS submissions for new products and product changes as required to ensure timely approvals for clinical studies and market release.
¡¤ Provide support to currently-marketed products as necessary. This includes reviewing labeling, promotional material, product changes and documentation for changes requiring government approval. Interact directly with MFDS.
¡¤ Provide business and product information to international regulatory staffs to enable development of strategies and requirements, and communicate that information to business teams.
¡¤ Provide feedback and on-going support to product development teams for regulatory issues and questions.
¡¤ Follow all work/quality procedures to ensure quality system compliance and high quality work.
Profile requirements:
Valuable assets:
¡¤ Good oral and excellent written communication skills.
¡¤ Effective interpersonal skills.
¡¤ Proficient computer skills.
¡¤ Effective team member.
¡¤ Ability to comprehend principles of engineering, physiology and medical device use. Good analytical thinking skills.
¡¤ Experience working with technical documentation.
¡¤ Project management skills. Ability to effectively manage multiple projects and priorities.
¡¤ Experience with International Standards (ISO, GMP)
¡¤ Experience in price reimbursement approvals for new technologies
¡¤ Experience in managing clinical studies.
¡¤ Solid relationships with MFDS.
¡¤ Knowledge of the business goals, products, therapy, customer needs, reimbursement, and competitive environment.
Job Package:
Salary and bonus negotiable depending on experience and background.
Á÷¾÷Á¤º¸Á¦°ø»ç¾÷½Å°í¹øÈ£ J150002023003