Senior Regulatory Affairs Specialist – Vascular (on-site)

Abbott is a global healthcare leader that helps people live more fully at all stages of life. This position is an on-site opportunity working out of our Santa Clara, or Temecula, CA locations in the Abbott Vascular Division. The Senior Regulatory Affairs Specialist provides support for the regulatory department to ensure efficient and compliant business processes and environment.

Requirements

• Strategic Planning
• Provide regulatory input to product lifecycle planning.
• Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes.
• Assess the acceptability of quality, preclinical and clinical documentation for submission filing.
• Compile, prepare, review and submit regulatory submissions to authorities.
• Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies.

Benefits

• Career development with an international company where you can grow the career you dream of
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement
• The Freedom 2 Save student debt program
• FreeU education benefit
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune