RA Specialist

The Opportunity

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most – home to hospital, lab to clinic.

Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all.

Key Responsibilities

The RA Specialist will play a key role in submissions to ensure the successful delivery of an overall regulatory plan. The role will be exposed to a variety of regulatory activities and, in time, will be given the opportunity to take on more strategic regulatory responsibilities as the role grows alongside personal capability and potential. Keeping track of submissions activity assigned & keep Managers & relevant stakeholders updated on the progress

Responsibility for the leadership of, preparation, and review of day to day regulatory submissions with full accountability for delivery Accountability for larger submissions as part of an overall project plan i.e. initial submissions and responses to questions Ensuring quality of both own and teamwork and compliance with regulatory guidelines and process within the required timelines Liaising with Regulatory Agencies to resolve straight forward issues in relation to their accountabilities Implementation of the submission strategy Responsible for the maintenance activities associated with an Approved product Prepare the document and manage the process for new product registration & maintenance/update of existing product licenses & KGMP requirements with MFDS under supervising of Regulatory Affairs manager Prepare the document and manage the process and deliver submissions to MFDS in the earliest possible time and ensure that all submissions for the re-evaluation Communicate with manufacturing sites to get the required documents and product dossiers Anticipate regulatory environmental changes and take appropriate actions to cope with the situation Appropriate documentation process reflecting environment changes and government policy tendency Support to new product registrations, renewal of Certificate, Develop Local IFU and Label in alignment with regulatory approval; Develop and/or update the local label/IFU and PMF per the approved license; Review and approve the promotion materials; Support review and evaluate the regulatory Changes/Trends, lead the actions to address the changes and minimization the business impact;

Others

Compliant with all the applicable regulations and QuidelOrtho policy;

Support the business tendering;

Collaboration & Team Work

Collaborate with all country/function for continuously improvement on Quality & regulatory Compliance in QuidelOrtho Korea; Other assignments, whenever necessary.

Minimum Requirements

Education: Bachelor’s or master’s degree in Biosciences, Chemistry, Engineering, Pharmacy or equivalent field.

Experience:

A minimum of 3-5 years RA experience in IVD or medical device products and strong background in working directly with MFDS Language: Fluent English speaking, writing, and reading.

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