(preferably EST and CST time zones)
We are seeking a committed Risk Analyst to strengthen our team. This foundational role is key to ensuring the security and integrity of our products, aligning them with the topmost standards of safety and compliance, including FDA guidelines for risk management. You will play a pivotal role in pinpointing, evaluating, and addressing cybersecurity risks through both the initial development and post-launch phases. This position provides a distinct chance to contribute towards the safety and effectiveness of medical devices, significantly impacting patient care.
What you will be doing:
- You will perform thorough risk assessments targeting cybersecurity threats and vulnerabilities in connected medical devices.
- You will work in synergy with multidisciplinary teams to weave cybersecurity risk management into every phase of product development.
- You will create and manage risk management documentation, ensuring alignment with FDA and other applicable standards.
- You will need to stay abreast of industry trends, threat intelligence, and regulatory shifts that affect medical device cybersecurity.
- You will lead risk management processes, including identification, assessment, evaluation, and mitigation of risks.
- You will participate in ongoing surveillance of marketed products to uncover and mitigate new risks and vulnerabilities.
- You will aid in refining and enhancing risk management policies, procedures, and tools.
Requirements:
- Prior experience working in a heavily regulated industry is a must
- Expertise in assessing risk and knowledge of frameworks pertinent to cybersecurity and medical devices.
- Acquaintance 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.
- Any skills with data analysis tools like Excel, SmartSheet and/or PowerBI
