Sr Prin Regulatory Affairs Specialist

Medtronic UK

United States
Base: $156,800.00 - $235,200.00; bonus/equity: sho...
Global regulatory strategies
Class ii robotic devices
Us and eu regulatory requirements
The Senior Principal Regulatory Affairs Specialist will play a key role in creating regulatory strategies and submissions to bring new robotic products to the global markets

Job Summary

  • The Senior Principal Regulatory Affairs Specialist will play a key role in creating regulatory strategies and submissions to bring new robotic products to the global markets.
  • Responsibilities are performed through the collaboration with various functions across the business unit, including but not limited to Regulatory Affairs, Research and Development, Clinical, Quality, and Marketing.
  • Medtronic offers a competitive Salary and flexible Benefits Package including health, dental, vision insurance, 401(k) with match, and paid time off.

Matching Summary

The Senior Principal Regulatory Affairs Specialist will play a key role in creating regulatory strategies and submissions to bring new robotic products to the global markets.

Salary

Base: $156,800.00 - $235,200.00; Bonus/Equity: Short-term incentive (MIP); Benefits: Health, Dental, Vision, HSA, FSA, Life Insurance, LTD, Dependent Daycare FSA, Tuition Assistance, 401(k) match, ESPP

Skills & Requirements

Must-have

  • global regulatory strategies
  • Class II robotic devices
  • US and EU regulatory requirements
  • product development core teams
  • technical documentation review
  • regulatory submissions worldwide

Nice-to-have

  • strategic thinking and planning
  • work cooperatively at all levels
  • balance priorities independently
  • creative regulatory strategies
  • deal with advanced concepts

Key Requirements

  • Bachelor’s degree required
  • Minimum of 10 years relevant experience
  • Advanced degree with 8 years relevant experience
  • Experience with US and EU submissions
  • Complex medical device systems experience

Work Rights

Not specified

Sponsorship: available

Tailored Resume

Cover Letter