Senior Regulatory Affairs Specialist

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. Varian Medical Systems, a Siemens Healthineers company is hiring a Senior Regulatory Affairs Specialist in Austin, TX as 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. What You Will Do 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 brings 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. What You Will Have Bachelor’s degree in Engineering / Life Sciences (advanced degree preferred) 7+ years of progressive experience in regulatory affairs, clinical and quality assurance preferably Class II and Class III medical devices Demonstrated experience with pre‑ and post‑market medical device submissions such as 510(k), IDE, PMA, Presubmissions, DeNovos, EU Technical Files, and Design Dossiers. Experience in the use of clinical data to support regulatory submissions (e.g., expansion of indications) Experience with international filings (Australia, Japan, China, Latin America, etc.) is a plus. Strong ability to interpret regulations, identify regulatory data needs, and solve regulatory issues. Ability to balance detailed execution with broader regulatory strategy development. Strong knowledge of regulations and standards: 21 CFR Part 11/820, ISO 13485, ISO 14971, IEC 60601, IEC 62304, IEC 62366, ISO 10993. Demonstrated ability to work independently and collaboratively in a fast‑paced, ambiguous environment. Strong judgment and comfort making regulatory recommendations under uncertainty. Clear, concise verbal and written communication skills across diverse audiences. Highly organized with strong prioritization and project management skills. Proficiency in MS Word, Excel, PowerPoint, and Adobe. Must be able to travel as needed. What Will Set You Apart Experience with international filings (Australia, Japan, China, Latin America, etc.) Background in interventional oncology products, electromechanical devices and software in medical devices (SiMD/SaMD) RAC certification (U.S. or EU) The Base Pay Range For This Position Is $112,420 – $154,572 Benefits Medical insurance Dental insurance Vision insurance 401(k) retirement plan Life insurance Long‑term and short‑term disability insurance Paid parking/public transportation Paid time off Paid sick and safe time Equal Employment Opportunity Statement Siemens Healthineers is an Equal Opportunity and affirmative action employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law. Reasonable Accommodations Siemens Healthineers is committed to equal employment opportunity. As part of this commitment, we will ensure that persons with disabilities are provided reasonable accommodations. #J-18808-Ljbffr