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Market Coordinator

2 months ago

Chelmsford, Essex, United Kingdom ZOLL Full time
Job Summary

ZOLL is seeking a highly skilled Market Coordinator to join our team in Chelmsford, MA. As a key member of our Post Market Surveillance program, you will be responsible for ensuring compliance with regulatory requirements worldwide.

Key Responsibilities
  • Develop and implement strategies to maintain ZOLL's Post Market Surveillance in compliance with applicable regulations worldwide.
  • Stay up-to-date with regulatory landscape updates, changes, and best practices.
  • Support initiatives to implement and assess gaps in the Quality Management System as it relates to Post Market Surveillance.
  • Ensure reporting requirements are compliant with ZOLL Policy in accordance with applicable laws and regulations worldwide.
  • Communicate effectively with regulatory agencies, including the FDA.
  • Maintain regular status reports of regulatory activities.
  • Support Competent Authority inquiries, Adverse Event & Serious Injury reporting, and Risk Management activities worldwide.
Requirements
  • Bachelor's Degree preferred.
  • Certification in Regulatory Affairs program preferred.
  • Knowledge of commonly used concepts, practices, and quality tools in a medical device environment.
  • Proficient with MS Office, including Excel, Access, PowerPoint, Visio, and Word.
  • Oracle and Agile experience preferred.
What We Offer
  • Dental insurance.
  • Health insurance.
  • Life insurance.
  • Paid time off.
  • 8 hour shift.
  • Monday to Friday.
Work Location

Hybrid remote in Chelmsford, MA 01824.