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 115,000 colleagues serve people in more than 160 countries. ## **JOB DESCRIPTION:** **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](https://www.abbott.com/corpnewsroom/strategy-and-strength/tackling-student-debt-for-our-employees.html) student debt program and [FreeU](https://www.abbott.com/corpnewsroom/strategy-and-strength/college-degree-for-free-its-possible-with-freeu.html) 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. **The Opportunity** Abbott is seeking a passionate, experienced **Regulatory Affairs Specialist** to join our Vascular Division team on-site in Santa Clara, CA or Temecula, CA. In this role, you will support EU and US regulatory activities and collaborate with the global regulatory organization to maintain regulatory compliance for a portfolio of endovascular medical devices used in the treatment of peripheral artery disease. The ideal candidate will possess strong analytical and project management skills, a working knowledge of medical device regulations, and the ability to interpret complex regulatory requirements and apply them to product development and lifecycle management activities. This role requires strong attention to detail, technical competence, and effective communication skills to collaborate across multiple functional areas to ensure regulatory considerations are integrated throughout the product lifecycle. Proven successful track record of preparing submissions and documentation in compliance with relevant medical device regulations is preferred. **What You’ll Work On** - Evaluate regulatory impact and develop global regulatory strategies to support product lifecycle management activities. - Prepare and support regulatory submissions for Vascular devices to achieve departmental and organizational objectives. - Assess proposed product, manufacturing, supplier, process, and labeling changes to determine regulatory impact and submission requirements across global markets. - Develop and document regulatory assessments supporting design control and change management activities. - Review and approve engineering change orders for protocols, reports, specifications, and other project related documentation supporting both new product development projects and sustaining activities. - Acts as a regulatory representative responsible for review and analysis of applicable regulatory guidelines. - Support maintenance of regulatory approvals and registrations for commercially marketed products. - Support the product release process by collaborating with the Regulatory Operations team and…