Regulatory Specialist Sr

Non-exempt position.

Requirements

• Minimum of 7 years of experience in Medical Device Regulatory Affairs
• Considered highly experienced with regulatory change assessments
• Working knowledge in US Medical Device Submissions

Responsibilities

• Participates in 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

Pay

$45–$50/hour based on experience.