Siemens Healthineers · 1 month ago
Senior Regulatory Affairs Specialist
Austin, TX
Full-time
Onsite
Mid, Senior Level
$94K/yr - $129K/yr
5+ years expSiemens Healthineers is a leader in medical technology, dedicated to pioneering breakthroughs in healthcare. The Senior Regulatory Affairs Specialist will collaborate with internal departments to ensure compliance with global regulatory requirements for medical devices, particularly in the Interventional Oncology business.
Health CareHealth DiagnosticsMedicalMedical Device
No H1B
Responsibilities
Collaboratively interface with a variety of levels on significant matters, often requiring coordination across organizational units
Outline submission and clearance requirements in assigned geographies
Develop sound regulatory strategies in alignment with business priorities and update strategies based upon regulatory changes
Effectively collaborate with product development, quality, and operations functions to identify applicable regulations/standards and assist with interpretation and compliance (e.g., ISO and IEC standards, ROHS, applicable sections of 21 CFR, regulatory agency guidance documents)
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 US, EU, and Canada; support international regulatory team with submissions to other geographies as required
Interact and negotiate directly with regulatory authorities during development and review processes to ensure clearance/approvals
Effectively communicate internally with cross-functional teams and externally with regulatory agencies
Evaluate proposed design, clinical, and manufacturing changes for regulatory impact and approve changes in compliance with regulatory requirements
Prepare and maintain annual licenses, registrations/listings for assigned geographies in a timely manner
Support product safety evaluation and reporting (e.g., MDR/Vigilance) as required by country regulation
Provide regulatory input for product recalls and recall communications
Support quality system and technical file/design dossier audits
Maintain regulatory files and tracking databases as required
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 the development of relevant data for regulatory submissions
Support internal and external audits
Qualification
Required
5+ years of progressive experience in regulatory affairs, clinical and quality assurance preferably Class II and Class III medical devices
Must have 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 knowledge of regulations and standards: 21 CFR Part 11/820, ISO 13485, ISO 14971, IEC 60601, IEC 62304, IEC 62366, ISO 10993
Bachelor's degree Engineering/ Life Sciences (advanced degree preferred)
Ability to work collaboratively and/ independently in a fast-paced environment while managing multiple priorities
Clear and effective verbal and written communication skills with diverse audiences and personnel
Highly organized with ability to manage multiple projects/tasks simultaneously and effectively prioritize
Proficiency in MS Word, Excel, Adobe, and PowerPoint
Must be able to travel as needed
Preferred
Experience with international filings (Australia, Japan, China, Latin America etc.) is a plus
Background in interventional oncology products, electromechanical devices and software in medical devices (SiMD/SaMD) is strongly preferred
RAC certification (U.S. or EU) is a plus
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
Siemens Healthineers
Siemens Healthineers is a healthcare technology company that provides diagnostic and therapeutic products and services. It is a sub-organization of Siemens.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$2.76BKey Investors
Ontario Together Fund
2021-05-25Grant· $2.5M
2021-03-25Post Ipo Equity· $2.76B
2018-03-16IPO
Leadership Team
Enno Nehrbass
SVP / Head of Strategy & Collaboration Mgmt Diagnostic Imaging
Sebastian Kronmueller
Vice President, Head of Strategy & Business Development - Laboratory Diagnostics
Recent News
2026-01-21
2026-01-20
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