Senior Regulatory Affairs Specialist

Follow your aspirations to Abbott for diverse opportunities, competitive salaries, great benefits, a 401(k) retirement savings plan, a company paid pension plan and profit sharing, all with a company providing the growth and strength to build your future.The Senior Regulatory Affairs Specialist will support international registrations of medical devices and IVD products in Latin America, Asia Pacific, and Canada. He/she will also be responsible for US regulatory submission activities that include the filing and/or creation of 510(k), PMA, Pre-IDEs, IDEs, and Technical File dossiers, as required. This individual will work with the Manager of Regulatory Affairs to implement strategies that will ensure the timely introduction of blood glucose monitoring systems into the domestic and international markets, and will participate in design control activities by serving as the regulatory resource in product design and development teams. In addition, he/she will interact with the FDA or other regulatory agencies or competent authorities to resolve issues arising during the regulatory submission review process.QualificationsDegree in Life Sciences and/or Biomedical Engineering required, as well as Medical device submissions experience (510(k), PMA, IDE), and a thorough understanding of design controls and risk management as they relate to FDA Quality System Regulations. International regulatory experience is also required.RAC Certification, and/or graduate degree in Regulatory Affairs a plus. Degree in Life Sciences or Biomedical EngineeringAbbott welcomes and encourages diversity in our workforce. EEO/AATo apply for this position, click here.To learn more about Abbott and view other opportunities, click here.