Regulatory Affairs Manager - Orthopedics

Smith & Nephew

Base: $96,500.00 - $167,500.00 usd annually; bonus...
Hybrid
7 years regulatory affairs experience
Orthopedic device industry background
Global regulatory strategy development
The role involves leading a team of project managers and regulatory professionals to shape global regulatory strategies for orthopedic technologies

Job Summary

  • The role involves leading a team of project managers and regulatory professionals to shape global regulatory strategies for orthopedic technologies.
  • Candidates will oversee critical submissions including 510(k), PMA, and MDR Technical Files while ensuring compliance with US and EU regulations.
  • Smith & Nephew offers a comprehensive benefits package including 401k matching, flexible work models, and extensive wellness programs.

Matching Summary

The role involves leading a team of project managers and regulatory professionals to shape global regulatory strategies for orthopedic technologies.

Salary

Base: $96,500.00 - $167,500.00 USD annually; Bonus/Equity: Entitled to receive bonus; Benefits: Medical, dental, vision, 401k, tuition reimbursement

Skills & Requirements

Must-have

  • 7 years regulatory affairs experience
  • Orthopedic device industry background
  • Global regulatory strategy development
  • Team leadership and coaching
  • US and EU regulatory knowledge

Nice-to-have

  • RAC certification preferred
  • Mergers and acquisitions experience
  • Inclusive team culture fostering
  • Project management sub-organization building

Key Requirements

  • Bachelor's degree in engineering or scientific discipline
  • Minimum 7 years combined regulatory and project management experience
  • Proven leadership capability in matrixed or direct management roles
  • RAC certification (preferred)

Work Rights

Not specified

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