Sr. Regulatory Professional

Job Title: Sr. Regulatory Professional Job Location: Raleigh, NC, USA Job Location Type: Remote Job Contract Type: Full-time Job Seniority Level: Mid-Senior level Job DescriptionThis is an exciting opportunity to be part of the future of Precision Medicine! Our mission is to improve the human condition by bringing the power of precision medicine to laboratories, partners, and patients globally. Our employees are passionate about their contributions because there is a very direct connection to helping patients with cancer. In the Companion Diagnostics Business (CDx), our team partners with leading pharmaceutical companies to develop, manufacture, and commercialize highly regulated medical devices which are critical for physicians to help select therapies for their patients. As the Regulatory Companion Diagnostics Professional, you will ensure compliance to medical device and CDx IVD regulations globally. In conjunction with other groups in Global Regulatory Affairs, the CDx Regulatory Affairs Department communicates with worldwide health authorities in the licensing of all products in development or currently marketed globally. The Regulatory Professional integrates broad business concepts and strategies into structured projects leading design and delivery of new products and solutions as a key technical contributor. The ability to tackle complex, high-impact project design problems is required. Main Responsibilities Develops and implements programs and processes to ensure that company products are safe, legal and meet or exceed customer expectations for compliance with national/regional/global regulations. Prepares document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements and company policies. Compiles materials required in submissions, license renewal, and annual registrations and maintains updated information about national/regional/global regulatory requirements. P