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Risk Management Specialist

1 month ago

Reston, Virginia, United States MiSource Full time
Job Title: Risk Analyst

At MiSource, we are seeking a highly skilled Risk Analyst to join our team. This role is crucial in ensuring the security and integrity of our products, aligning them with the topmost standards of safety and compliance, including FDA guidelines for risk management.

Key Responsibilities:

  • Perform thorough risk assessments targeting cybersecurity threats and vulnerabilities in connected medical devices.
  • Collaborate with multidisciplinary teams to integrate cybersecurity risk management into every phase of product development.
  • Develop and manage risk management documentation, ensuring alignment with FDA and other applicable standards.
  • Stay up-to-date with industry trends, threat intelligence, and regulatory shifts that affect medical device cybersecurity.
  • Lead risk management processes, including identification, assessment, evaluation, and mitigation of risks.
  • Participate in ongoing surveillance of marketed products to uncover and mitigate new risks and vulnerabilities.
  • Contribute to refining and enhancing risk management policies, procedures, and tools.

Requirements:

  • Prior experience working in a heavily regulated industry is essential.
  • Expertise in assessing risk and knowledge of frameworks pertinent to cybersecurity and medical devices.
  • Familiarity with FDA regulations and best practices for medical device risk management.
  • Exceptional analytical and critical thinking skills, with a meticulous approach to risk analysis.
  • Strong interpersonal and teamwork skills, with the ability to engage effectively with both technical and non-technical colleagues.
  • Proficiency in data analysis tools like Excel, SmartSheet, and/or PowerBI.