Shellie Oestreicher

Background

About Shellie Oestreicher

With 24 years of expertise in Regulatory Affairs and a proven ability to lead global regulatory strategy in the medical device industry, I bring deep experience in navigating complex regulatory landscapes and delivering successful regulatory submissions for market access worldwide. As a highly driven Regulatory Affairs executive, I am adept at managing and leading high performing global teams, driving cross-functional alignment, and overseeing the development and execution of strategic programs that ensure compliance with evolving global regulatory standards. I have a track record of optimizing regulatory processes, enhancing time-to-market, and mitigating risks for medical devices. My leadership experience spans roles such as Head of Global Regulatory Strategy, and Manager of International Regulatory Affairs, managing product registrations in 200+ countries. I am skilled in managing budgets, resources, and complex projects, ensuring that regulatory requirements are seamlessly integrated into product development and commercial strategies. Key strengths include: • Global Regulatory Affairs & Strategy • Cross-Functional Leadership & Team Development • Regulatory Submissions & Compliance • Post-Market Management & Line Extensions • Regulatory Agency Interaction & Negotiation • Regulatory Process Optimization • Life Cycle Management (LCM) & New Product Development • International Regulatory Guidelines (ISO, FDA, EU MDR, ISO 14971, IEC, REACH, ROHS, applicable sections of 21 CFR, regulatory agency guidance documents) • Risk Management & Strategic Problem Resolution • Regulatory Affairs Training & Mentorship • Quality Management System Audits (MDSAP, KGMP, Japan QMS) • Regulatory Due Diligence & Mergers & Acquisitions I am an advocate for regulatory excellence and have been actively involved in industry groups like RAPS and MITA and AdvaMed. I have also been asked by my local colleagues to contribute to the growth of the regulatory community by serving as a founding member of the Pittsburgh RAPS Chapter.