Regulatory Specialist Sr

Advises development/marketing teams on manufacturing changes, line extensions, technical labeling, and applicable regulations/interpretations. Experience with regulatory strategy, risk management, regulatory policy & intelligence, and continuous improvement activities.

Job Title: Sr. Regulatory Specialist
Duration: 6+ Months Contract (Possibility of Extension)
Location: Alameda, CA 94502
Shift: 9:00 AM 5:00 PM

Job Description:

• Must have 7+ years of experience in Medical Device Regulatory Affairs.
• Highly experienced in regulatory change assessments.
• Working knowledge of U.S. Medical Device Submissions.
• Experience with regulatory strategy, risk management, regulatory policy & intelligence, and continuous improvement activities.
• Ensures timely approval of new medical devices and continued approval of marketed products.
• Serves as a regulatory representative for cross-functional teams.
• Advises development/marketing teams on manufacturing changes, line extensions, technical labeling, and applicable regulations/interpretations.