Varian · 2 weeks ago
Senior Regulatory Affairs Specialist
United States
Full-time
Remote
Senior Level
$112K/yr - $155K/yr
7+ years expVarian Medical Systems, a Siemens Healthineers company, is seeking a Senior Regulatory Affairs Specialist in Austin, TX. The role involves delivering regulatory strategy and execution for products within the Interventional Oncology business, requiring strong regulatory judgment and the ability to navigate evolving regulatory requirements.
HealthcareManufacturingMedical DeviceSoftwareHealth Care
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
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
Qualification
Required
Bachelor's degree 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)
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
Preferred
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)
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
Company
Varian
Varian Medical Systems is a manufacturer of medical devices and software for treating cancer and other medical conditions. It is a sub-organization of Siemens Healthineers.
10001+ employees
H1B Sponsorship
Varian has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
3%
Represents job field similar to this job
Legal and Compliance
Engineering and Development
Management and Executive
Customer Service and Support
Accounting and Finance
Human Resources
Education and Training
Sales
Product Management
Marketing
Creatives and Design
Trends of Total Sponsorships
*2026 (15)
2025 (59)
2024 (54)
2023 (46)
2022 (102)
2021 (62)
2020 (64)
Funding
Current Stage
Public CompanyTotal Funding
unknown2020-08-02Acquired
1999-03-25IPO
Leadership Team
Spencer Sias
VP Investor Relations & Corporate Communications
Thomas J. Yorkey
Vice President, New Product Solutions
Recent News
Medical Xpress - latest medical and health news stories
2026-07-16
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