Senior Regulatory Specialist

Years Experience: Must have 7 years of experiences in Medical Device Regulatory Affairs

• Considered as highly experienced with regulatory change assessments.
• Working knowledge in US Medical Device Submissions
• Participates in some of the following: continuous improvement activities, product plan development and implementation, regulatory strategy, risk management, regulatory policy and intelligence.
• Ensures timely approval of new medical devices and continued approval of marketed products.
• Serves as regulatory representative to cross-functional teams.