Specialist, Medical Affairs

BD

Franklin Lakes, NJ, USA
Base: $106,600.00 - $175,900.00 usd annual; bonus:...
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Bachelor's degree in biomedical or life sciences
1 year experience in quality or medical affairs
Knowledge of fda regulations and iso standards
** BD is seeking a Specialist for Medical Affairs focused on Post-Market Surveillance for Specimen Management, responsible for compliance reporting and data management. Ideal candidates should have a background in biomedical sciences or related fields, with experience in quality assurance or medical affairs. **

Job Summary

  • The Specialist, Medical Affairs is responsible for coordinating post-market surveillance reports and ensuring alignment with US, EU, Canada, and other regional regulations.
  • This role requires a deep understanding of technical principles applicable to in vitro diagnostics and the ability to manage proactive customer quality response activities.
  • BD offers a competitive compensation package including annual bonus potential, comprehensive health benefits, and a culture prioritizing on-site collaboration for innovation.

Matching Summary

Match Score: 75

** BD is seeking a Specialist for Medical Affairs focused on Post-Market Surveillance for Specimen Management, responsible for compliance reporting and data management. Ideal candidates should have a background in biomedical sciences or related fields, with experience in quality assurance or medical affairs. **

Salary

Base: $106,600.00 - $175,900.00 USD Annual; Bonus: Annual Bonus Potential and Discretionary LTI Bonus; Benefits: Comprehensive health, dental, vision, 401(k), and wellness programs

Skills & Requirements

Must-have

  • Bachelor's degree in biomedical or life sciences
  • 1 year experience in Quality or Medical Affairs
  • Knowledge of FDA regulations and ISO standards
  • Understanding of IVD-R and EU MDR/IVDR
  • Strong written documentation and communication skills

Nice-to-have

  • PhD in relevant scientific field
  • Technical writing or publication history
  • Familiarity with BD products and processes
  • Professional certification in medical affairs or QA
  • Experience with CyberGrants portal management

Key Requirements

  • Bachelor's degree required
  • Minimum 1 year experience in Quality, Medical Affairs, or Clinical Research
  • Must have knowledge of FDA, ISO, and IVD regulations

Work Rights

Not specified

Tailored Resume

Cover Letter