This job is no longer available
There are still lots of open positions. Let's find the one that's right for you.
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. The Medical Device Regulatory Affairs Development (RAD) Program offers several opportunities for individuals to engage in specialized work assignments and analyses, evaluation, preparation, and submission of documentation for regulatory registration. This ensures that products and procedures comply with regulatory agency specifications. The program includes three 1-year rotations located in various cities including Alameda, Pleasanton, Santa Clara, CA, Minneapolis, MN, or Plano, TX. In this role, you will assist in the preparation of regulatory applications, including annual reports, to achieve departmental and organizational objectives. You will create, review, and approve engineering changes, acting as a regulatory representative responsible for the review and analysis of applicable regulatory guidelines. Your responsibilities will also include reviewing and evaluating communications to ensure they convey all necessary detail and adhere to applicable regulatory standards set by the FDA or other worldwide regulatory agencies. You will maintain pertinent domestic and international medical device regulations to ensure submission requirements worldwide are current and up-to-date. Additionally, you will support the product release process by creating GTS licenses or reviewing and approving requests for product release. You may interface directly with the FDA and other regulatory agencies as directed. This position requires compliance with U.S. Food and Drug Administration (FDA) regulations, international regulations, and other regulatory requirements, as well as company policies and operating procedures. You will maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors, and perform other related duties as assigned.
