Rongrong Sun
Sr Regulatory Affairs Specialist Ii @Candela Medical
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WORK HISTORY
Sr Regulatory Affairs Specialist Ii @Candela Medical
US
Lead preparation and submission of Class II medical device dossiers for multiple APAC markets (China, Japan, S. Korea, Malaysia, Philippines, Singapore, etc.).• Develop and execute regulatory strategies for new and modified devices.• Conduct regulatory impact assessments for design and manufacturing changes.• Support global regulatory audits (MDSAP, KGMP).• Manage interns and local regulatory specialists, providing mentoring and performance development.
EDUCATION
Harbin Institute of Technology
Bachelor's degree, Civil Engineering
Washington State University
Doctor of Philosophy - PhD, Mechanical Engineering
Harbin Institute of Technology
Master's Degree, Civil Engineering
SKILLS
ABOUT RONGRONG SUN
Experienced Regulatory Affairs Specialist and Laser Scientist with over 10 years in medical device development and regulatory strategy. Proven expertise in laser design & development; regulatory submissions across APAC, and cross-functional project leadership.
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