Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist

Jump into a role that leverages your regulatory expertise to drive innovation in healthcare. For everyone. Everywhere. Sustainably. We offer a global community that celebrates diversity and individuality.

Under the direction of Regulatory Affairs Management, the Senior Regulatory Affairs Specialist serves as a decision‑maker on regulatory issues for Varian Medical Systems, Inc. (a Siemens Healthineers Company), specifically within the Interventional Oncology business. This on‑site role is available in Austin, Texas or Shoreview, Minnesota and requires less than 20% travel.

Base pay range: $93,680 – $140,520 per year.

• Collaboratively interface with various organizational levels on significant matters.
• Outline submission and clearance requirements in assigned geographies.
• Develop and update regulatory strategies aligned with business priorities and regulatory changes.
• Collaborate with product development, quality, and operations to identify applicable regulations and assist with interpretation and compliance (e.g., ISO, IEC, 21 CFR, ROHS).
• 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.
• Interact and negotiate directly with regulatory authorities during development and review processes.
• Communicate effectively internally and externally with cross‑functional teams and regulatory agencies.
• Evaluate proposed design, clinical, and manufacturing changes for regulatory impact and approve changes in compliance.
• Prepare and maintain annual licenses, registrations and listings for assigned geographies.
• Support product safety evaluation and reporting (e.g., MDR/Vigilance).
• Provide regulatory input for product recalls and recall communications.
• Support quality system and technical file/design dossier audits.
• Maintain regulatory files and tracking databases.
• 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 developing relevant data for regulatory submissions.
• Support internal and external audits.

• 5+ years of progressive experience in regulatory affairs, clinical and quality assurance for 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.
• International filing experience (Australia, Japan, China, Latin America, etc.) is a plus.
• 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.
• Ability to manage details while contributing to broader regulatory strategies.
• Ability to follow scientific arguments, identify regulatory scientific data needs, and solve regulatory issues.

• Bachelor’s degree in Engineering or Life Sciences (advanced degree preferred).
• RAC certification (U.S. or EU) is a plus.

• Ability to work collaboratively or independently in a fast‑paced environment while managing multiple priorities.
• Clear and effective verbal and written communication skills.
• Highly organized with ability to manage multiple projects/tasks simultaneously.
• Proficiency in MS Word, Excel, Adobe, and PowerPoint.
• Must be able to travel as needed.

• Medical, dental, and vision insurance.
• 401(k) retirement plan.
• Life insurance.
• Long‑term and short‑term disability insurance.
• Paid parking/public transportation.
• Paid time off and sick and safe time.

Siemens Healthineers is an Equal Opportunity and affirmative action employer encouraging diversity in the workplace. All qualified applicants will receive consideration for…