Senior Regulatory Affairs Specialist at Siemens Healthineers

Job description

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions. Analyzes the requirements and prepares product related regulatory submissions. The Senior Regulatory Affairs Specialist is a hands-on individual contributor who partners closely with cross-functional teams to deliver regulatory strategy and execution for products within the Interventional Oncology business. This role requires strong regulatory judgment, comfort navigating ambiguity, and the ability to translate evolving regulatory requirements into clear, actionable guidance. Under the direction of Regulatory Affairs Management, the Senior RA Specialist independently owns regulatory assessments, develops regulatory strategy options, and partners with senior leadership on final regulatory decisions. This role is well-suited for a regulatory professional who thrives in fast-paced NPI environments and brings both execution excellence and sound decision-making. This role combines knowledge of scientific, regulatory, and business issues to ensure that products are developed, manufactured, and distributed in compliance with global regulatory requirements. Under the direction of Regulatory Affairs Management, the Senior Regulatory Affairs Specialist acts as a decision-maker on regulatory issues, assures that registration/renewal deadlines are met, and provides critical regulatory support for new product development. This is a hybrid in the Austin TX with less than 20% travel requirements. Key Responsibilities Serve as a regulatory partner to R&D, Quality, Clinical, Manufacturing, Operations, and Marketing teams across NPI and sustaining activities. Independently assess regulatory impact for new products and changes, and provide clear regulatory pathway recommendations. Develop and maintain regulatory strategies aligned with business priorities and evolving regulatory requirements. Interpret and apply applicable regulations, standards, and guidance (e.g., FDA, EU MDR, Health Canada and ROW) and translate them into practical development guidance. Review and approve R&D, quality, preclinical, and clinical documentation for regulatory submissions. Compile, prepare, review, and submit high-quality regulatory submissions in the U.S., EU, and Canada; support international filings as needed. Support regulatory authority interactions by drafting briefing materials, responses, and correspondence. Prepare and maintain licenses, registrations, and listings for assigned geographies. Support product safety reporting (e.g., MDR, Vigilance), recalls, audits, and regulatory inspections. Maintain regulatory files, systems, and tracking databases. Identify emerging regulatory issues and proactively provide guidance to functional teams. Exercise sound, ethical judgment in compliance with regulations and company policy. Manage multiple priorities concurrently with accuracy and accountability. Decision-Making & Operating Model · Owns regulatory assessments and change impact determinations. · Develops regulatory pathway options and brings clear recommendations. · Identifies emerging regulatory risks, gaps, and opportunities and proactively bringing forward strategic recommendations. · Translates regulatory requirements in terms of risk, timeline, cost and business impact · Partners with Regulatory Affairs Management on final regulatory decisions. · Supports regulatory authority interactions through preparation and documentation. Qualifications Regulatory Role Specific: · 7+ years of progressive experience in regulatory affairs, clinical and quality assurance preferably Class II, Class III medical devices and software medical devices · Demonstrated experience with pre- and post-market me