Principal Regulatory Affairs Specialist (business Partnerships).
AbbVie
Alameda, CA, United States
Base: $86,700.00 – $173,300.00; bonus/equity: not ...
Global regulatory submissions experience
Regulatory compliance management
Medical device regulatory knowledge
Abbott is a global healthcare leader focused on life-changing technologies across diagnostics, medical devices, nutritionals, and branded generic medicines
Job Summary
Abbott is a global healthcare leader focused on life-changing technologies across diagnostics, medical devices, nutritionals, and branded generic medicines.
The Principal RA Specialist will drive regulatory strategy for breakthrough diabetes management and digital health business partnership initiatives.
Employees have access to career development, excellent benefits including free medical coverage, retirement plans, tuition reimbursement, and a diverse and inclusive work environment.
Matching Summary
Abbott is a global healthcare leader focused on life-changing technologies across diagnostics, medical devices, nutritionals, and branded generic medicines.
Salary
Base: $86,700.00 – $173,300.00; Bonus/Equity: Not specified; Benefits: Free medical coverage, retirement savings plan, tuition reimbursement
Skills & Requirements
Must-have
global regulatory submissions experience
regulatory compliance management
medical device regulatory knowledge
regulatory strategy development
cross-functional team collaboration
regulatory documentation and labeling review
regulatory liaison and negotiation
Nice-to-have
experience with digital health technologies
working in matrixed global environment
strong verbal and written communication
project planning and timeline management
problem solving and independent work
multitasking and prioritization skills
experience with regulatory crisis management
Key Requirements
Bachelor’s Degree in Scientific discipline
5+ years experience with Class II/III medical devices or biologics
experience with 21 CFR 820 and ISO 13485 standards
knowledge of Medical Devices Directive and IVD Directive
experience with 510(k) applications and PMA supplements