Risk Manager - Washington, United States - Cynet Systems

Cynet Systems Washington, United States

3 weeks ago

Description

Job Description

Job Description

We are looking for

Risk Manager

for our client in

Washington, DC

Job Title:
Risk Manager

Job Location:
Washington, DC

Job Type:
Contract

Job Description:

Responsibilities:

This opportunity seeks a Medical Device Risk Manager to lead a dedicated team focused on remediating existing Risk Management Files for the Digital Oncology portfolio.

Candidates in Central and Eastern time zones are preferred.

As a leader in Risk Management, candidate will oversee efforts for Varian's software Product portfolio, with a primary focus on Digital Oncology Information system (OIS) software products.

Responsibilities include remediating existing clinical software Risk Management Files, collaborating with healthcare software development teams, and ensuring comprehensive implementation of risk control measures in alignment with Varian's risk management procedure and ISO 14971 standards.

Skills and Knowledge:
Proficient in business tools such as Outlook and Microsoft Office.
Bachelor's degree in Healthcare, Science, or Engineering with extensive related experience.
Minimum of 5 years of relevant experience in medical device risk management or digital electronic health record systems.
Minimum of 5 years of relevant experience in Healthcare Software Development.
Proficiency in ISO 13485, ISO 14971, FDA CFR 820, EU 2017/745, IEC 62304, IEC 82304, and IEC/TR standards.
Experience in medical device risk analysis, evaluation of risk control measures, and validation testing.
Excellent interpersonal skills and understanding of international safety standards for medical devices.

Desired experience Class II or III ( class IIb or III) medical devices, Software as a Medical Device (SaMD), and Cybersecurity Risk management.

Company Description visit our career site to see all open positions @

Company Description

visit our career site to see all open positions @
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