Senior Regulatory Affairs Specialist (columbia, Md)

Smith+Nephew

Columbia, MD, US
Base: $101,500.00 to $152,250.00 usd annually; bon...
Hybrid
Regulatory submissions expertise
Fda 510(k) experience
Hct/p regulatory knowledge
The Senior Regulatory Affairs Specialist will lead regulatory submissions and design strategies for HCT/P projects

Job Summary

  • The Senior Regulatory Affairs Specialist will lead regulatory submissions and design strategies for HCT/P projects.
  • This role involves assessing regulatory impacts and ensuring compliance with FDA regulations.
  • Smith+Nephew offers competitive benefits and fosters a culture of inclusion and continuous improvement.

Matching Summary

The Senior Regulatory Affairs Specialist will lead regulatory submissions and design strategies for HCT/P projects.

Salary

Base: $101,500.00 to $152,250.00 USD annually; Bonus/Equity: Not specified; Benefits: Medical, dental, vision coverage, 401(k), PTO

Skills & Requirements

Must-have

  • Regulatory submissions expertise
  • FDA 510(k) experience
  • HCT/P regulatory knowledge

Nice-to-have

  • Strong communication skills
  • Collaborative team player
  • Critical thinking abilities

Key Requirements

  • Bachelor’s degree in Chemistry or Biology
  • 5 years of Regulatory Affairs experience
  • Regulatory Affairs Certification preferred

Work Rights

Not specified

Tailored Resume

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