"As a Manager in Regulatory Affairs at Stryker, I am dedicated to ensuring that our medical innovations meet and exceed the highest industry standards. With a keen eye for compliance and a passion for driving positive change in the healthcare landscape, I lead with a commitment to excellence and a focus on achieving regulatory milestones. Join me on the journey of shaping the future of healthcare through innovation, integrity, and regulatory expertise."As a seasoned Regulatory Affairs professional, I bring extensive regional expertise and a proven track record in steering project setup, start-up, and development toward timely and successful strategic outcomes. I specialize in interfacing with key functional areas—product core teams, clinical teams, EU and US regulatory bodies, and marketing risk management groups—to orchestrate the seamless development of regulatory plans.My role at Stryker involves handling international submissions and regulatory processes for product development and registration, showcasing my proficiency in navigating the intricacies of global regulatory frameworks. I am a certified ISO 13485:2016 Lead Auditor, ensuring a meticulous approach to quality management systems.Adept at reviewing development quality reports and plans, I ensure the adequacy of information required for submissions. Coordinating with regulatory agencies, I facilitate discussions on clinical and regulatory reports, including clinical assessment results. My expertise extends to preparing and reviewing Clinical Evaluation Reports (CER) for various class II & III devices for EU submissions as per MED DEV 2.7.1 rev 4.With a sound understanding of EUMDR regulations and subsequent guidance documents, I coordinate with Notified Bodies for submissions and CE Marking. Additionally, I review design changes to ensure accuracy in legacy medical device technical files and identify potential gaps.My analytical prowess shines through in synthesizing vast amounts of pre-clinical data, risk management assessments, literature, clinical investigation results, and field performance data to evaluate product safety and performance.I possess excellent planning and tracking skills, coupled with strong organizational abilities and effective time management. As someone trained in Risk Management (ISO 14971) and Usability Standards (IEC 62366-1:2015), I bring a holistic approach to regulatory affairs and quality assurance.Let's connect to explore opportunities for collaboration and advancement within the dynamic landscape of regulatory affairs and quality assurance.