Dongwook Min
Regulatory Project Manager at Mitek Sports Medicine
- Role
- Regulatory Project Manager at Johnson & Johnson MedTech
- Location
- Bloomington, IN, US
- LinkedIn followers
- 500 followers
About Dongwook Min
Identify, coordinate planning, set a goal, and implement values the functional business needs.
Experience
Regulatory Project Manager
May 2021 — Present
Lead and mentor a team of five Regulatory Affairs Professionals- Attend monthly regulatory council meeting as a regulatory lead- Attend recurring project meeting with various stakeholders including local regulatory teams and business lead- Developing a project tracker that provides more detail status of projects- Manage devices registration project status and report the project status for strategic markets- Participated MDSAP audit as a RA SME and got certified with no NC and no observations.
Education
Indiana University Indianapolis
Master of Business Administration - MBA, Business Administration and Management, General
2018 — 2020
Northeastern University
Master of Science (MS), Pharmacy Administration and Pharmacy Policy and Regulatory Affairs
2012 — 2014
Indiana University Bloomington
BS, Accounting and Finance
2008 — 2010
Skills
- Biotechnology
- Iso 13485
- Auditing
- Microsoft Excel
- Powerpoint
- Pharmaceutical Industry
- Fda
- Cross-Functional Team Leadership
- Regulatory Requirements
- Management
- Regulatory Affairs
- Ms Office Suite
- Life Sciences
- Medical Devices
- Microsoft Office
- Negotiation
- Validation
- Financial Analysis
- Clinical Trials
- Project Management
- Regulatory Submissions
- Public Speaking
- Process Improvement
- Gmp
- Quality System
- Quality Assurance
- Microsoft Word
- Team Leadership
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