Senior Specialist, Research Medical Device Combination Products - Onsite

Merck & Co., Inc.

Rahway, NJ, USA
Base: $106,200.00 - $167,200.00; bonus/equity: ann...
Hybrid
Gmp compliance for medical devices
Method validation and transfer activities
Clinical supply release testing
The role involves supporting the development and commercialization of medical device and combination products through rigorous GMP testing and analytical support

Job Summary

  • The role involves supporting the development and commercialization of medical device and combination products through rigorous GMP testing and analytical support.
  • Candidates will be responsible for validating test procedures, managing investigations, and authoring technical reports in compliance with ALCOA principles.
  • The position offers a competitive salary range of $106,200.00 to $167,200.00 along with comprehensive benefits including medical, dental, vision, and 401(k) retirement plans.

Matching Summary

The role involves supporting the development and commercialization of medical device and combination products through rigorous GMP testing and analytical support.

Salary

Base: $106,200.00 - $167,200.00; Bonus/Equity: Annual bonus and long-term incentive eligible; Benefits: Medical, dental, vision, 401(k), paid holidays, vacation

Skills & Requirements

Must-have

  • GMP compliance for medical devices
  • Method validation and transfer activities
  • Clinical supply release testing
  • ALCOA data documentation principles
  • Cross-functional team collaboration

Nice-to-have

  • Hands-on experience with ISO standards
  • FDA and MDR regulatory familiarity
  • Leading cross-functional teams
  • Engineering study design verification
  • Statistical analysis skills

Key Requirements

  • PhD degree or 4 years experience with MS
  • 7 years experience with BS in Science or Engineering
  • No visa sponsorship available

Work Rights

Not specified

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