Senior Regulatory Affairs Specialist

Siemens Healthineers

Austin, TX, US
Base: $107,060 - $147,213; bonus/equity: not speci...
Hybrid
Regulatory strategy and execution
Medical device submissions
Global regulatory requirements
Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably

Job Summary

  • Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably.
  • 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.
  • The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan.

Matching Summary

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

Salary

Base: $107,060 - $147,213; Bonus/Equity: Not specified; 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

Skills & Requirements

Must-have

  • regulatory strategy and execution
  • medical device submissions
  • global regulatory requirements
  • cross-functional team collaboration
  • regulatory authority interactions

Nice-to-have

  • comfort navigating ambiguity
  • fast-paced NPI environments
  • scientific, regulatory, and business issues
  • ethical judgment
  • prioritization and project management skills

Key Requirements

  • 7+ years of progressive experience in regulatory affairs
  • Demonstrated experience with pre- and post-market medical device submissions
  • Experience with international filings
  • Bachelor’s degree Engineering/ Life Sciences
  • RAC certification (U.S. or EU) is a plus

Work Rights

Not specified

Tailored Resume

Cover Letter