Regulatory Affairs Specialist Ii – Heart Failure (on-site)
Abbott
Pleasanton, CA, United States
Base: $81,500.00 – $141,300.00; bonus/equity: not ...
Prepare regulatory applications
Review engineering changes
Interface with regulatory agencies
Abbott's Heart Failure (HF) business pioneers and increases access to lifesaving, connected innovations that empower people to take control of their health
Job Summary
Abbott's Heart Failure (HF) business pioneers and increases access to lifesaving, connected innovations that empower people to take control of their health.
The Regulatory Affairs Specialist II will prepare robust regulatory applications, create/review engineering changes, and interface with regulatory agencies.
Employees have access to career development, medical coverage, retirement savings plan, tuition reimbursement, and are recognized as a great place to work.
Matching Summary
Abbott's Heart Failure (HF) business pioneers and increases access to lifesaving, connected innovations that empower people to take control of their health.
Salary
Base: $81,500.00 – $141,300.00; Bonus/Equity: Not specified; Benefits: Medical coverage, retirement savings plan, tuition reimbursement
Skills & Requirements
Must-have
prepare regulatory applications
review engineering changes
interface with regulatory agencies
maintain medical device regulations
support product release process
Nice-to-have
work with cross-functional teams
positive and cooperative communication
analytical and critical thinking
work in a fast-paced environment
ethical standards of regulatory profession
Key Requirements
Minimum 2 years experience in regulated industry
Bachelor's degree or equivalent experience
Experience with 510(k) or PMA supplements
Experience with EU/international medical device regulations