Abbott is a global healthcare leader providing innovative vascular products and a supportive work environment with career development and comprehensive benefits
Job Summary
Abbott is a global healthcare leader providing innovative vascular products and a supportive work environment with career development and comprehensive benefits.
The Principal Regulatory Affairs Specialist will develop global regulatory strategies, prepare submissions, and serve as a regulatory expert for Class III vascular devices.
Employees have access to excellent medical coverage, retirement plans, tuition reimbursement, and work in a company recognized for diversity and employee satisfaction.
Matching Summary
Abbott is a global healthcare leader providing innovative vascular products and a supportive work environment with career development and comprehensive benefits.
Salary
Base: $100,000.00 – $200,000.00; Bonus/Equity: Not specified; Benefits: Medical coverage, retirement savings plan, tuition reimbursement
Skills & Requirements
Must-have
Regulatory submissions for medical devices
Knowledge of 21 CFR 820 and ISO 13485
Experience with Class III devices
FDA and international product registrations
Regulatory strategy development
Compliance with US and EU regulations
Nice-to-have
Strong analytical and problem-solving skills
Ability to manage multiple priorities
Experience with combination products
Strong communication and organizational skills
Experience working on project teams
Attention to detail
Key Requirements
Bachelor’s Degree in Scientific discipline
5-7 years regulated industry experience
Experience with PMA and IDE submissions
Knowledge of Medical Devices Directive and IVD Directive