Abbott is focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions
Job Summary
Abbott is focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions.
The Principal Regulatory Affairs Specialist will develop global regulatory strategies and lead submissions for continuous glucose monitoring systems at the Alameda, CA location.
Employees have access to career development, excellent medical coverage, retirement plans, tuition reimbursement, and a diverse, inclusive work environment.
Matching Summary
Abbott is focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions.
Salary
Base: $100,000.00 – $200,000.00; Bonus/Equity: Not specified; Benefits: Medical coverage, retirement savings, tuition reimbursement
Skills & Requirements
Must-have
Regulatory submissions for medical devices
Knowledge of 21 CFR 820 and ISO 13485
Premarket submission strategy
Compliance with Medical Device Regulation
Interface with regulatory agencies
Regulatory risk evaluation
Nice-to-have
Experience with digital health technology
Cross-division business unit collaboration
Strong verbal and written communication
Problem-solving and independent work
Multitasking and prioritization skills
Key Requirements
Bachelor’s Degree in Scientific discipline
5 years experience with Class II/III devices or biologics