Senior Regulatory Affairs Lead — Medical Devices (Hybrid)

Regulatory Toolkit; Austin (TX); Hybrid; USD 116,000 - 159,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k)

Life insurance

Disability insurance

Paid parking/public transportation

Paid time off

Paid sick time

Job summary

Siemens Healthineers in Austin, TX is seeking a Senior Regulatory Affairs Specialist to lead regulatory strategy and execution for Interventional Oncology products. The role is a hands-on contributor partnering with R&D, Quality, Clinical, and Manufacturing to ensure compliant development, submission, and maintenance across the U.S., EU, and Canada.

The position is hybrid in Austin with travel less than 20%.

Qualifications

• 7+ years of progressive experience in regulatory affairs for medical devices and software medical devices
• Experience with pre- and post-market submissions such as 510(k), IDE, PMA, Presubmissions, DeNovos, EU Technical Files, and Design Dossiers
• Experience with international filings (Australia, Japan, China, Latin America etc.) is a plus
• Strong ability to interpret regulations, identify data needs, and solve regulatory issues
• Knowledge of 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 across NPI and sustaining activities.
• Independently assess regulatory impact for new products and changes; provide pathway recommendations.
• Develop and maintain regulatory strategies aligned with business priorities and evolving requirements.
• Interpret and apply regulations; translate them into practical development guidance.
• Review and approve documentation for regulatory submissions (R&D, quality, preclinical, clinical).
• Prepare and maintain licenses, registrations, and listings for assigned geographies.

Skills

Regulatory submissions

FDA regulations

Global filings

Cross-functional collaboration

Regulatory strategy

Education

Bachelor’s degree Engineering/Life Sciences

RAC certification

Job description

Siemens Healthineers in Austin, TX is seeking a Senior Regulatory Affairs Specialist to lead regulatory strategy and execution for Interventional Oncology products. The role is a hands-on contributor partnering with R&D, Quality, Clinical, and Manufacturing to ensure compliant development, submission, and maintenance across the U.S., EU, and Canada.

The position is hybrid in Austin with travel less than 20%.