Abbott is a global healthcare leader creating breakthrough science to improve people’s health, with a portfolio spanning diagnostics, medical devices, nutritionals, and branded generic medicines
Job Summary
Abbott is a global healthcare leader creating breakthrough science to improve people’s health, with a portfolio spanning diagnostics, medical devices, nutritionals, and branded generic medicines.
The Associate Director, Regulatory Affairs will set strategy, direct preparation of submissions, and interface with regulatory agencies to obtain timely product approvals.
Abbott offers comprehensive benefits including medical coverage, retirement savings plan, tuition reimbursement, and a company recognized as a great place to work globally.
Matching Summary
Abbott is a global healthcare leader creating breakthrough science to improve people’s health, with a portfolio spanning diagnostics, medical devices, nutritionals, and branded generic medicines.
Salary
Base: $129,300.00 – $258,700.00; Bonus/Equity: Not specified; Benefits: Medical coverage, retirement savings plan, tuition reimbursement
Skills & Requirements
Must-have
Regulatory submissions
Product registration worldwide
Interface with regulatory agencies
Guidance on regulatory requirements
Quality Assurance
Manufacturing
Research & Development
Nice-to-have
Anticipating changes in medical science
Career development
Employee well-being
Diverse and inclusive workplace
Key Requirements
Bachelor’s Degree or equivalent experience
5-7 years' experience in a regulated industry
5-7 years' regulatory experience preferred
Experience with 510k / PMA submissions
Experience with hardware/software devices
Familiarity with Predetermined Change Control Plans (PCCPs)