Risk Manager

Cynet Systems • Washington, DC, US • 5m ago

Job Description:

Responsibilities:

Lead Risk Management efforts for Varian's Digital Oncology Information system (OIS) software products.
Remediate existing clinical software Risk Management Files, including.
Risk management plans.
Hazard analyses.
Risk assessments.
Post-market surveillance.
Collaborate with healthcare software development teams as a risk management file owner.
Ensure comprehensive implementation of risk control measures in the clinical software according to Varian’s risk management procedures and ISO 14971.

Skills and Knowledge:

Bachelor’s degree in Healthcare, Science, or Engineering.
Several years of related experience.
At least 5 years of experience in medical device risk management or digital electronic health record systems.
At least 5 years of experience in Healthcare Software Development.
Knowledge of ISO 13485, ISO 14971, FDA CFR 820, EU 2017/745, IEC 62304, IEC 82304, and IEC/TR 80002-1.
Experience in medical device risk analysis, risk control measure evaluation, implementation, and validation testing.
Strong interpersonal skills.
Understanding of international safety standards for medical devices.
Experience with Class II or III ( Class IIb or III) medical devices is highly desired.
Experience with Software as a Medical Device (SaMD), Risk analysis, and Cybersecurity Risk management.
Proficient in using business tools such as Outlook and Microsoft Office.

Desirable Experience:

Hands-on experience with Class II or III (Class IIb or III) medical devices.
Experience in Software as a Medical Device (SaMD).
Knowledge in Cybersecurity Risk management related to healthcare software.

Related Jobs

IT Systems Administrator

Cultural Vistas • Washington, DC, US • 12h ago

12h ago

Senior DevSecOps Engineer / Architect with Security Clearance

OneGlobe LLC • Remote (Washington, DC, US) • 14h ago

14h ago

Director of Digital Forensics

Aksa Power Generation USA • Washington, DC, US • $140k - $175k / year • 15h ago

15h ago

Security Analyst 3

Oracle • Washington, DC, US • $49 - $81 / hour • 15h ago

15h ago

Head of Security Engineering, Google Public Sector

Google • Washington, DC, US • $171k - $257k / year • 17h ago

17h ago

MSP Systems Administrator - Arlington, Virginia

FusionTek • Arlington, VA, US • $65k - $85k / year • 17h ago

17h ago

Cloud Systems Administrator

Motion Recruitment • Remote (Rockville, MD, US) • 17h ago

17h ago

Global Technology Analyst Program - 2025

Bank of America • Washington, DC, US • 17h ago

17h ago

Cyber Systems Engineer

SkyePoint Decisions, Inc. • Arlington, VA, US • $98k - $108k / year • 19h ago

19h ago

Linux Vulnerability Management Engineer

Guidehouse • Remote (District of Columbia, United States, US) • $86.50k - $129.70k / year • 19h ago

19h ago