Senior Regulatory Affairs Specialist – Vascular (on-site)

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries.

Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to: 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 and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree 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 A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents. This Senior Regulatory Affairs Specialist position is an on-site opportunity working out of our Santa Clara, or Temecula, CA locations in the Abbott Vascular Division. As an individual contributor, the function of a Senior Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient and compliant business processes and environment.  The individual may execute tasks and play a consultative role by partnering across business functions to support continued on-market access of products or new product development.  This new team member may assist in identifying data needed, obtaining these data and ensuring that they are effectively presented for the registration of products worldwide.  The individual may prepare and submit documentation needed for registration worldwide or may oversee such preparation. WHAT YOU’LL DO Strategic Planning: Provide regulatory input to product lifecycle planning. Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes. Understand, investigate and evaluate regulatory history/background of class, disease/ therapeutic/diagnostic context in order to assess regulatory implications for approval. Determine and communicate submission and approval requirements. Participate in risk-benefit analysis for regulatory compliance. Premarket: Assess the acceptability of quality, preclinical and clinical documentation for submission filing. Compile, prepare, review and submit regulatory submissions to authorities. Monitor impact of changing regulations on submission strategies. Monitor applications under regulatory review. Monitor and submit applicable reports to regulatory authorities. Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies. Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval. Postmarket: Maintain annual licenses, registrations, and listings. Assist in compliance with product post-marketing approval requirements. Assess external communications relative to regulations. Assist with labeling development and review for compliance before release. Support change management process to assess regulatory impact of change and consequent submission requirements. Analyze the impact of cumulative product