R&d Specialist, Medical Device Stability

Medline Industries LP

Base: $79,000.00 - $119,00.00 annual; bonus/equity...
Not specified
Bachelor of science in chemistry or biology
2 years experience in medical device or pharma
Knowledge of fda requirements and interactions
Medline Industries is seeking an R&D Specialist in Medical Device Stability to support product development by writing stability protocols, evaluating stability data, and ensuring compliance with regulatory standards. The ideal candidate will have a background in chemistry or biology, with at least two years of experience in a related field, particularly in medical devices or pharmaceuticals

Job Summary

  • This role is critical for setting expiration dates for medical devices, drugs, and cosmetics through rigorous stability support.
  • The specialist will author stability protocols, evaluate data trends, and ensure compliance with FDA and other regulatory requirements.
  • Medline offers a competitive salary range of $79,000 to $119,000 along with comprehensive benefits including health insurance and 401(k) contributions.

Matching Summary

Match Score: 85

Medline Industries is seeking an R&D Specialist in Medical Device Stability to support product development by writing stability protocols, evaluating stability data, and ensuring compliance with regulatory standards. The ideal candidate will have a background in chemistry or biology, with at least two years of experience in a related field, particularly in medical devices or pharmaceuticals.

Salary

Base: $79,000.00 - $119,00.00 Annual; Bonus/Equity: Bonus and/or incentive eligible; Benefits: Health insurance, life, disability, 401(k), PTO

Skills & Requirements

Must-have

  • Bachelor of Science in Chemistry or Biology
  • 2 years experience in medical device or pharma
  • Knowledge of FDA requirements and interactions
  • Experience with risk assessment and root cause analysis
  • Ability to write stability protocols and reports

Nice-to-have

  • Experience with CE technical files
  • ISO 11607 knowledge for performance testing
  • LIMS experience for protocol and report management
  • Self-starter with strong organizational skills
  • Willingness to travel up to 10%

Key Requirements

  • Bachelor of Science degree required
  • Minimum 2 years industry experience
  • FDA interaction experience preferred

Work Rights

Not specified

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