We're an innovative medical technology company whose purpose is to enable healthier lives everywhere, every day. While we discover and develop groundbreaking products and services that benefit everyone, we are especially passionate about those that advance women's health and well being. This allows us to be a company that prospers, grows and empowers women to experience healthier lives. None of this would be possible without the talent, skills and aspirations of our employees. Their expertise and dedication to developing and sharing more robust, science based certainty drives our increasingly global presence, as well as a pipeline that responds to the unmet health and wellness needs of women, families and communities. What powers our growth across Breast Skeletal Health, Diagnostic Solutions, and GYN Surgical Solutions is also what differentiates us: the exceptional and clinically proven ability of our products to detect, diagnose and treat illnesses and other health conditions earlier and better. This clinical superiority creates high expectations, which we fulfill by always challenging ourselves to improve health through better technology, education and market access. Our goal is to minimize doubt and maximize the confidence our customers and their patients have in their decisions and diagnoses. We work toward this goal every day, always aware that in an increasingly complex and competitive global environment, we must continually earn the trust of our customers and their patients. By focusing on women's health while still delivering health benefits to everyone, we are setting a new standard of excellence that is strengthened by purpose, driven by passion and brought to life by our promise of more certain early detection and better health outcomes.As a leading innovator of women's health, we at Hologic are empowering people to live healthier lives everywhere, every day.Our quality and regulatory affairs teams are responsible for keeping abreast of new, changing and existing regulatory requirements. They lead the development and implementation of a global vision for regulatory affairs, government relations, quality management and market access, to influence strategic and operational plans.As our Regulatory Affairs Specialist, you will support and manage regulatory activities for Hologic Diagenode. From providing expert guidance during product development to preparing and submitting regulatory dossiers, you'll be instrumental in ensuring our products meet both domestic and international compliance standards. What To ExpectAct as the regulatory representative in product development teams, offering guidance on global regulatory requirements.Develop and execute regulatory strategies for domestic and international submissions.Provide input on product design, labeling, clinical studies, and risk management.Prepare, compile, and follow up on pre market and post market submissions.Monitor and interpret new and updated regu