Principal Scientist, Drug/device Combination Products

Laboratory Animal Management Association

New Jersey, United States
$153,800.00 - $242,200.00; bonus/equity: eligible ...
Hybrid
Combination product design controls
Risk management processes
Operational excellence tools
This position will be responsible for leading and implementing medical device and combination product design controls for both new products and inline products from early design concept definition through commercialization to support regulatory filing, product launch, and post-market surveillance

Job Summary

  • This position will be responsible for leading and implementing medical device and combination product design controls for both new products and inline products from early design concept definition through commercialization to support regulatory filing, product launch, and post-market surveillance.
  • The role will also be responsible for leading and supporting continuous improvement initiatives related to design control and risk management processes for combination products.
  • The salary range for this role is $153,800.00 - $242,200.00.

Matching Summary

This position will be responsible for leading and implementing medical device and combination product design controls for both new products and inline products from early design concept definition through commercialization to support regulatory filing, product launch, and post-market surveillance.

Salary

$153,800.00 - $242,200.00; Bonus/Equity: eligible for annual bonus and long-term incentive; Benefits: medical, dental, vision, 401(k), paid holidays, vacation, sick days

Skills & Requirements

Must-have

  • combination product design controls
  • risk management processes
  • operational excellence tools
  • global regulatory requirements
  • cross-functional development teams
  • device-drug integration

Nice-to-have

  • influence without formal authority
  • drive sustainable results
  • foster cross-functional collaboration
  • strategic thinker

Key Requirements

  • 15 years related experience with B.A./B.S. or 12 years with Master's
  • 10+ years process improvement experience
  • Combination product/medical device development experience
  • Hands-on combination products experience
  • Led DHF deliverables
  • Knowledge of US and global regulations
  • Experience with FMEA, statistical sampling, control strategy

Work Rights

Not specified

Sponsorship: available

Tailored Resume

Cover Letter