Senior Regulatory Affairs Specialist

Siemens Healthineers in; 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

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions.

Analyzes the requirements and prepares product related regulatory submissions.

The Senior Regulatory Affairs Specialist is a hands-on individual contributor who partners closely with cross-functional teams to deliver regulatory strategy and execution for products within the Interventional Oncology business. This role requires strong regulatory judgment, comfort navigating ambiguity, and the ability to translate evolving regulatory requirements into clear, actionable guidance.

Under the direction of Regulatory Affairs Management, the Senior RA Specialist independently owns regulatory assessments, develops regulatory strategy options, and partners with senior leadership on final regulatory decisions. This role is well-suited for a regulatory professional who thrives in fast-paced NPI environments and brings both execution excellence and sound decision-making. This role combines knowledge of scientific, regulatory, and business issues to ensure that products are developed, manufactured, and distributed in compliance with global regulatory requirements. Under the direction of Regulatory Affairs Management, the Senior Regulatory Affairs Specialist acts as a decision-maker on regulatory issues, assures that registration/renewal deadlines are met, and provides critical regulatory support for new product development. This is a hybrid in the Austin TX with less than 20% travel requirements.

Key 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.

Decision-Making & Operating Model

• Owns regulatory assessments and change impact determinations.
• Develops regulatory pathway options and brings clear recommendations.
• Identifies emerging regulatory risks, gaps, and opportunities and proactively brings 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.

Qualifications

Regulatory Role Specific:

• 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.

Nice to have:

• Experience with international filings (Australia, Japan, China, Latin America etc.)
• Background in interventional oncology products, electromechanical devices and software in medical devices (SiMD/SaMD)

Educational background:

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

Other qualifications:

• 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

Who we are: We are a team of more than 72,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.

How we work: When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual’s potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world’s most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

To find out more about Siemens Healthineers businesses, please visit our company page here.

The base pay range for this position is:

$115,740 - $159,137

Factors which may affect starting pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate.

If this is a commission eligible position the commission eligibility will be in accordance with the terms of the Company's plan. Commissions are based on individual performance and/or company performance.

• 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 and Affi…

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