Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist Join Siemens Healthineers as a Senior Regulatory Affairs Specialist, an individual contributor responsible for ensuring products meet global regulatory requirements for the Interventional Oncology business of Varian Medical Systems, Inc. This on-site role is available in Austin, Texas or Shoreview, Minnesota with less than 20% travel and does not sponsor visas. Key Responsibilities Collaboratively interface with various levels and coordinate across organizational units on significant matters. Outline submission and clearance requirements for assigned geographies. Develop sound regulatory strategies aligned with business priorities and update them based on regulatory changes. Collaborate with product development, quality, and operations to identify applicable regulations/standards and assist with interpretation and compliance (ISO, IEC, ROHS, 21 CFR, agency guidance). Review and approve R&D, quality, preclinical and clinical documentation for submission filing. Compile, prepare, review, and submit high‑quality regulatory submissions to authorities on time in the US, EU and Canada; support international regulatory team with submissions to other geographies as required. Interact and negotiate directly with regulatory authorities during development and review processes to ensure clearance/approvals. Communicate effectively internally with cross‑functional teams and externally with regulatory agencies. Evaluate proposed design, clinical and manufacturing changes for regulatory impact and approve changes in compliance with regulatory requirements. Prepare and maintain annual licenses, registrations/listings for assigned geographies in a timely manner. Support product safety evaluation and reporting (MDR/Vigilance) as required by country regulation. Provide regulatory input for product recalls and recall communications. Support quality system and technical file/design dossier audits. Maintain regulatory files and tracking databases as required. Evaluate import/export requirements. Identify emerging issues and provide guidance to functional groups. Exercise good and ethical judgment within policy and regulations. Perform multiple tasks concurrently with accuracy. Provide guidance to functional groups in the development of relevant data for regulatory submissions. Support internal and external audits. Qualifications Regulatory Role Specific 5+ years progressive experience in regulatory affairs, clinical and quality assurance preferably Class II and Class III medical devices. Experience with pre‑ and post‑market medical device submissions such as 510(k), IDE, PMA, presubmissions, DeNovos, EU Technical Files and Design Dossiers. Experience using clinical data to support regulatory submissions (e.g. expansion of indications). Experience with international filings (Australia, Japan, China, Latin America, etc.) is a plus. Ability to follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues. Strong knowledge of regulations and standards: 21 CFR Part 11/820, ISO 13485, ISO 14971, IEC 60601, IEC 62304, IEC 62366, ISO 10993. Background in interventional oncology products, electromechanical devices and software in medical devices (SiMD/SaMD) is strongly preferred. Educational Background Bachelor’s degree in Engineering or Life Sciences; advanced degree preferred. RAC certification (US or EU) is a plus. Other Qualifications Ability to work collaboratively and independently in a fast‑paced environment while managing multiple priorities. Clear and effective verbal and written communication skills with diverse audiences and personnel. Highly organized with ability to manage multiple projects/tasks simultaneously and effectively prioritize. Proficiency in MS Word, Excel, Adobe, and PowerPoint. Must be able to travel as needed. Location & Travel On‑site at Austin, Texas or Shoreview, Minnesota;