Staff Clinical Evaluation Specialist (remote)

Stryker Corporation

United States
Base: $95,700 - $207,400 usd annual; bonus/equity:...
Fully remote
4+ years industry experience in clinical or regulatory affairs
3+ years direct experience authoring clinical evaluations
Bachelor of science degree in health or science discipline
Stryker Corporation is seeking a remote Staff Clinical Evaluation Specialist to develop and author clinical and regulatory documentation for medical devices. The role requires collaboration across multiple teams to ensure high-quality submissions and compliance with global regulations

Job Summary

  • This role involves leading the development of high-quality clinical and regulatory documentation to enable global market availability for medical devices.
  • Candidates will collaborate closely with Regulatory, Clinical Research, Quality, and Marketing teams to ensure successful submission-ready document preparation.
  • The position requires independently resolving content questions and negotiating with global regulatory bodies to ensure successful submission acceptance.

Matching Summary

Match Score: 85

Stryker Corporation is seeking a remote Staff Clinical Evaluation Specialist to develop and author clinical and regulatory documentation for medical devices. The role requires collaboration across multiple teams to ensure high-quality submissions and compliance with global regulations.

Salary

Base: $95,700 - $207,400 USD Annual; Bonus/Equity: Not specified; Benefits: Not specified

Skills & Requirements

Must-have

  • 4+ years industry experience in clinical or regulatory affairs
  • 3+ years direct experience authoring clinical evaluations
  • Bachelor of Science degree in health or science discipline
  • Ability to synthesize complex clinical data into compliant documents
  • Experience with FDA and EU MDR regulatory requirements

Nice-to-have

  • Master's or PhD in health or science field preferred
  • Strong cross-functional collaboration and negotiation skills
  • Experience translating data for diverse audiences including regulators
  • Proven success managing complex projects in regulated environments

Key Requirements

  • Bachelor of Science in health or science required
  • Minimum 4 years industry experience in clinical, quality, or regulatory affairs
  • At least 3 years authoring clinical evaluations for medical devices
  • US work authorization required (Remote within United States)

Work Rights

Must be based in the United States

Tailored Resume

Cover Letter