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 Expect Act 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 regulations, ensuring internal stakeholders are informed. Update and manage regulatory procedures to support continuous process improvements. Support stakeholders in implementing new regulatory requirements and on-market activities. What We Expect Education: Bachelor's degree in life sciences, engineering or a similar discipline Knowledge: Understanding the regulatory standards for IVD's and medical devices is advantageous Skills: Strong communication skills, and the ability to interpret and explain standards to cross functional stakeholders Curiosity: An interest in the life science field, and a passion to continue learning the changes in requirements landscape Organisation: Strong organisational skills with the ability to pivot across numerous projects at any time. Ability to work in a fast-paced environment Independence and Initiative: Proactive approach to your work, with the mindset of continuous improvement and development of processes and ideas Why Hologic? We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and ... Global Regulatory, Clinical Research, Medical Devices, Health System, Regulatory Strategy, Projects, Regulation, Labelling, Proactivity, Risk Management, Engineering, VOS, Fast Pace, Team Building, Life Science, Passion, Lead development, Landscaping, Product Development, Regulatory Affairs, Industrial design, Continuous Process, Development Process, Process Development, Organization Skills, Implementation Originele vacature is te vinden op StepStone.be – Maak nu een Jobagent aan op StepStone en vind je droombaan! https://bit.ly/2jPYsZC Vind gelijkaardige jobs, informatie over werkgevers en carrièretips op StepStone.be!
Original job ad is published on StepStone.be - Set up a Jobagent at StepStone now and find your dream job! https://bit.ly/2jPYsZC For similar jobs, information on employers and career tips visit StepStone.be!
La version originale de cette offre d'emploi est disponible sur stepstone.be – Créez maintenant votre Job Agent sur StepStone et trouvez le job de vos rêves ! https://bit.ly/2jPYsZC Trouvez des jobs similaires, des informations sur les employeurs qui recrutent et des conseils de carrière sur stepstone.be!