Massachusetts Licensed Medical Device Safety Specialist

A company is looking for an Associate Director, Medical Device Safety Specialist. Key Responsibilities Ensure organizational compliance with relevant medical device legislations and regulations Prepare, review, and approve regulatory compliance documents for internal and external audiences Develop and implement compliance programs and operational plans Required Qualifications, Training, and Education Bachelor's Degree in a health-related discipline, preferably Nursing or Biomedical Engineering Minimum of 5 years' experience in device safety or device quality assurance roles in the pharmaceutical industry or CRO Proficiency with office tools and safety/quality databases Understanding of risk management and device risk analysis Experience with compliance requirements of EU Medical Device Regulation and FDA regulations

Apr 16, 2025 - 19:48

A company is looking for an Associate Director, Medical Device Safety Specialist. Key Responsibilities Ensure organizational compliance with relevant medical device legislations and regulations Prepare, review, and approve regulatory compliance documents for internal and external audiences Develop and implement compliance programs and operational plans Required Qualifications, Training, and Education Bachelor's Degree in a health-related discipline, preferably Nursing or Biomedical Engineering Minimum of 5 years' experience in device safety or device quality assurance roles in the pharmaceutical industry or CRO Proficiency with office tools and safety/quality databases Understanding of risk management and device risk analysis Experience with compliance requirements of EU Medical Device Regulation and FDA regulations