Regulatory Specialist Sr

Position Title: Regulatory Specialist Sr

Work Location: Alameda, CA

Assignment Duration: 6 months

• Years of Experience: Must have 7 years of experience in Medical Device Regulatory Affairs
• Considered highly experienced with regulatory change assessments.
• Working knowledge of 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.
• Advises development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations.