Regulatory Affairs Specialist II

Abbott is a global healthcare leader that helps people live more fully at all stages of life. We are recruiting for a Regulatory Affairs Specialist II to join our team in the Pleasanton, CA location. In this role, you will provide support for the regulatory department to ensure efficient and compliant business processes and environment.

Requirements

• Authors, coordinates, compiles and submits international regulatory submissions
• Prepares robust regulatory applications to achieve departmental and organizational objectives
• Represents RA on cross-functional product development and manufacturing support teams
• Maintains ongoing surveillance and analysis of all pertinent international medical device regulations
• Interfaces directly with regulatory agencies as needed
• Conducts reviews of product and manufacturing changes for compliance with applicable regulations

Benefits

• Training and career development
• Financial security through competitive compensation, incentives and retirement plans
• Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
• Paid time off
• 401(k) retirement savings with a generous company match