HyunJeong You
Sr. RAQA Manager
Scranton,PA
Summary
As an RA/QA proefessional with about 16 years of experience, made plans to enter the market as much as faster, maintained/kept compliances as the top priority, and strived to faciliate the flexibility in various regulations such as MD, pharmaceutical laws, EHS, etc.
Worked hard to strengthen individual capabilities so that to cover a variety of perspectives by taking charge of the In-vitro diagnostic market, which is not limited to medical device.
Insightful Manager with experience directing and improving operations through effective employee motivational strategies and strong policy enforcement. Proficient in best practices, market trends and regulatory requirements of industry operations. Talented leader with analytical approach to business planning and day-to-day problem-solving. Collaborative leader with dedication to partnering with coworkers to promote engaged, empowering work culture. Documented strengths in building and maintaining relationships with diverse range of stakeholders in dynamic, fast-paced settings. Dedicated Medical/IVD professional with history of meeting company goals utilizing consistent and organized practices. Skilled in working under pressure and adapting to new situations and challenges to best enhance the organizational business unit.
Overview
16
16
years of professional experience
4
4
years of post-secondary education
Work History
RA Manager
Becton Dickinson Korea
Seoul
05.2014 - Current
- Drived Regulatory activities and initiatives. As a key member of various project teams and responsible for development of regulatory strategies across multiple programs involving the different stakeholders.
- Contributed to the development strategy and lead in the planning, preparation, submission and maintenance of regulatory submissions and regulatory agency interactions. Planed re-evaluation/re-assessment and renewals including resource/budget allocation.
- Established, maintained and developed processes and procedures related to quality systems, and ensures ongoing and continuous conformance with internal, customer and regulatory requirements/regulations. Identified gaps for continuous improvement.
- Interpreted regulatory rules or rule changes and monitored communication through corporate policies and procedures.
- Worked with governance committees to make and evaluate plans.
- Kept up-to-date with changes in regulatory legislation and guidelines and obtained product approval.
- Represented company in Medical industry during communications with International RA folk.
- Consolidated global information relevant to product and monitored global submissions and approvals status.
- Prioritized project-related tasks to efficiently complete essential tasks.
- Reviewed submission data to assess compliance with Medical/IVD regulations.
- Manage the 3rd party warehouse/distribution center in accordance with corporate procedures and local requirements.
- Maximized performance by monitoring daily activities and mentoring team members.
- Delivered feedback to decision-makers regarding employee performance and training needs.
- Resolved staff member conflicts, actively listening to concerns and finding appropriate middle ground.
- Expanded cross-functional organizational capacity by collaborating across departments on priorities, functions and common goals.
RA&QA Manager
Carl Zeiss Korea
Seoul
11.2008 - 05.2014
- Interpreted regulatory rules or rule changes and monitored communication through corporate policies and procedures.
- Gathered, evaluated, organized, managed and collated information in varying formats.
- Prepared and submitted regulatory file applications and supporting documentation.
- Consolidated global information relevant to product and monitored/reviewed global submissions and approvals status.
- Performed and documented quality control checks to maintain compliance with company initiatives.
- Maintained and archived regulatory paperwork.
- Assured consistent quality of production by implementing and enforcing automated practice systems.
- Prepared reimbursement claim forms or related documents and reviewed for completeness.
- Enhanced availability of infrastructure through enterprise-wide planning, thorough testing, efficient implementation and comprehensive support for HTA process
- Worked with governance committees to make and evaluate plans.
RA&QA Manager
PSMED Medical
Seoul
01.2008 - 11.2008
- Performed/managed product registration projects and market launch.
- Maintained the importing system that included in Korean labeling and package insert, etc
- Communicated with headquater to capture the requirements for submissions/compliances
- Prepared and submitted regulatory file applications and supporting documentation.
- Performed and documented quality control checks to maintain compliance with company initiatives.
- Maintained and archived regulatory paperwork.
RA/QA Consultant
Medipole Consulting Company
Seongnam-si
11.2005 - 12.2007
- Performed & manage product registration projects and market launch
- Provided regular updates to team leadership on quality metrics by communicating consistency problems or production deficiencies.
- Developed monthly, end-of-quarter and other statistical reports for leadership team and quality improvement programs.
- Compiled and distributed weekly feedback to team leaders and managers to improve service time and quality while increasing productivity.
- Controlled/communicated with customer for sharing the status of project submission.
- Developed and maintained relationships with customers and suppliers through account development.
- Well trained in the field of Medical Device to fit RA/QA specialist
Education
Bachelor of Science - Food Scinece
Seoul National University of Science And Technolog
Seoul 03.2002 - 02.2006
Skills
Policies and procedures
Additional Information
Date of Birth: 1982.08.28
Gender : Female
Marital status : YES
residential address : Hwasung-si, Dongtan
Timeline
RA Manager
Becton Dickinson Korea
05.2014 - Current
RA&QA Manager
Carl Zeiss Korea
11.2008 - 05.2014
RA&QA Manager
PSMED Medical
01.2008 - 11.2008
RA/QA Consultant
Medipole Consulting Company
11.2005 - 12.2007
Bachelor of Science - Food Scinece
Seoul National University of Science And Technolog
03.2002 - 02.2006
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