Experience in regulatory submissions for medical devices
Knowledge of 21 cfr 820 and iso 13485 standards
Abbott is a global healthcare leader focused on helping people with diabetes manage their health effectively through life-changing technologies
Job Summary
Abbott is a global healthcare leader focused on helping people with diabetes manage their health effectively through life-changing technologies.
The Principal Specialist will provide subject-matter expertise to ensure efficient business processes while partnering across business functions to interpret emerging regulations.
Employees qualify for free medical coverage, an excellent retirement savings plan with high employer contribution, and tuition reimbursement benefits.
Matching Summary
Abbott is a global healthcare leader focused on helping people with diabetes manage their health effectively through life-changing technologies.
Salary
Base: $100,000.00 – $200,000.00; Bonus/Equity: Not specified; Benefits: Free medical coverage, retirement savings plan, tuition reimbursement
Skills & Requirements
Must-have
Bachelor's Degree in Scientific discipline
Experience in regulatory submissions for medical devices
Knowledge of 21 CFR 820 and ISO 13485 standards
Experience with EU Medical Devices Directive requirements
Ability to lead cross-functional working sessions
Nice-to-have
RAC certification from Regulatory Affairs Professionals Society
Advanced level degree in science or engineering fields
Proficiency with Veeva Vault and dashboarding tools
Experience in highly matrixed geographically diverse environments
Strong verbal and written communication skills
Key Requirements
Bachelor's Degree in Chemistry, Life Sciences, or Biology
Experience with IVD Directive (98/79/EC) or Medical Devices Directive
2-3 years of experience in regulatory affairs preferred