Senior Regulatory Affairs Specialist (columbia, Md)

Smith+Nephew

Columbia, MD, US
Base: $101,500.00 to $152,250.00 usd annually; bon...
Hybrid
5+ years regulatory affairs experience
Fda 510(k) submission leadership
Hct/p regulatory knowledge (21 cfr 1271)
The role involves leading regulatory submissions and defining strategies for Human Cells, Tissues, and Cellular and Tissue-Based products (HCT/P)

Job Summary

  • The role involves leading regulatory submissions and defining strategies for Human Cells, Tissues, and Cellular and Tissue-Based products (HCT/P).
  • Candidates will author FDA 510(k) submissions and serve as the regulatory lead in Agency interactions including Pre-Sub meetings.
  • The company offers competitive benefits including medical, dental, vision coverage, 401(k) matching, and generous PTO.

Matching Summary

The role involves leading regulatory submissions and defining strategies for Human Cells, Tissues, and Cellular and Tissue-Based products (HCT/P).

Salary

Base: $101,500.00 to $152,250.00 USD annually; Bonus/Equity: Competitive bonus and discounted stock options offered; Benefits: Medical, dental, vision, 401(k), tuition reimbursement, parental leave, and wellness offerings included.

Skills & Requirements

Must-have

  • 5+ years Regulatory Affairs experience
  • FDA 510(k) submission leadership
  • HCT/P regulatory knowledge (21 CFR 1271)
  • Device-led combination product strategy
  • Cross-functional team collaboration

Nice-to-have

  • RAC Devices certification preferred
  • Strong critical thinking skills
  • Culture of continuous improvement
  • Excellent oral and written communication
  • Proactive risk identification abilities

Key Requirements

  • Bachelor's degree in Chemistry, Biology, or related field
  • Minimum 5 years hands-on Regulatory Affairs experience
  • Demonstrated experience liaising directly with the FDA
  • Not specified visa sponsorship availability

Work Rights

Not specified

Tailored Resume

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