Principal Regulatory Affairs Specialist – Vascular (on-site)
AbbottSanta Clara, California, United States
Posted March 2, 2026
100000 - 200000 USD
Full Time
About the Company
Abbott is a global healthcare leader that helps people live more fully at all stages of life.
Job Description
Abbott is seeking a Principal Regulatory Affairs Specialist to join their Vascular Division on-site in Santa Clara, CA. The role involves providing regulatory guidance to cross-functional partners, developing global regulatory strategies, and preparing and submitting regulatory submissions.
Requirements
- Bachelor's Degree in Scientific discipline e.g. Chemistry, life Sciences, Biology (or equivalent vocational qualifications)
- Experienced in regulatory submissions for Pharmaceutical, In vitro diagnostic devices and/or medical devices
- Experience of working within the requirements of 21 CFR 820, ISO 13485, the Medical Devices Directive (93/42/EEC) and/or the IVD Directive (98/79/EC)
- Strong written, verbal, presentation, and organizational skills
- Strong analytical and problem-solving skills
- Working knowledge of QSR, ISO, and EN standards. Strong working knowledge of regulatory requirements for US, EU (EU MDR), and other international geographies
Benefits
- Free medical coverage in our Health Investment Plan (HIP) PPO medical plan
- Excellent retirement savings plan with high employer contribution
- Tuition reimbursement
- Freedom 2 Save student debt program
- FreeU education benefit
