Regulatory Affairs Lead - Medical Devices, Hybrid Austin

Siemens Healthineers AG; Austin (TX); Hybrid; USD 116,000 - 159,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan.

Life insurance

long-term and short-term disability 보험

Job summary

Siemens Healthineers in Austin, TX is seeking a Senior Regulatory Affairs Specialist to lead regulatory strategy and execution for Interventional Oncology products. You will partner with R&D, Quality, Clinical, Manufacturing, Operations and Marketing to secure timely approvals and compliant submissions.

This hands-on role demands strong regulatory judgment, experience with global submissions (FDA, EU MDR, Health Canada) and the ability to translate evolving requirements into actionable guidance

Qualifications

• 7+ years of progressive experience in regulatory affairs, clinical and quality assurance preferably Class II, Class III medical devices and software 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

Responsibilities

• Serve as 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 (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 (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

Job description

Siemens Healthineers in Austin, TX is seeking a Senior Regulatory Affairs Specialist to lead regulatory strategy and execution for Interventional Oncology products. You will partner with R&D, Quality, Clinical, Manufacturing, Operations and Marketing to secure timely approvals and compliant submissions.

This hands-on role demands strong regulatory judgment, experience with global submissions (FDA, EU MDR, Health Canada) and the ability to translate evolving requirements into actionable guidance