Senior Regulatory Affairs Specialist

Position Summary Senior Regulatory Affairs Specialist – Interventional Oncology – Austin, TX. Key Responsibilities Serve as a regulatory partner to R&D, Quality, Clinical, Manufacturing, Operations, and Marketing teams across new product introduction 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. Own regulatory assessments and change impact determinations. Develop regulatory pathway options and bring clear recommendations. Identify emerging regulatory risks, gaps, and opportunities and proactively bring forward strategic recommendations. Translate regulatory requirements in terms of risk, timeline, cost and business impact. Partner with Regulatory Affairs Management on final regulatory decisions. Support regulatory authority interactions through preparation and documentation. Qualifications Bachelor’s degree in Engineering, Life Sciences (advanced degree preferred) 7+ years of progressive experience in regulatory affairs, clinical and quality assurance for ClassII and ClassIII medical devices Demonstrated experience with pre‑ and post‑market medical device submissions such as 510(k), IDE, PMA, pre‑submissions, DeNovos, EU Technical Files, and Design Dossiers Experience in using clinical data to support regulatory submissions (e.g., expansion of indications) 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: 21CFRPart11/820, ISO13485, ISO14971, IEC60601, IEC62304, IEC62366, ISO10993 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 MSWord, Excel, PowerPoint, and Adobe Must be able to travel as needed (less than 20% travel) and work on‑site in Austin, TX Preferred Qualifications 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) #LS‑OS1 (if applicable) Compensation & Benefits Salary range: $112,420 – $154,572. Benefits include 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 andAffirmative Action Employer encouraging diversity in the workplace.All qualified applicants will receive consideration for employment withoutregard to 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, sexstereotyping, order of protection status, protected veteran or militarystatus, or an unfavorable discharge from military service, and othercategories protected by federal, state or local law. EEO is the Law: Applicantsand employees are protected under Federal law from discrimination. ReasonableAccommodations: Siemens Healthineers is committed to equal employmentopportunity. As part of this commitment, we will ensure that persons withdisabilities are provided reasonable accommodations. #J-18808-Ljbffr