Medical Specialist
The Judge Group Inc.

Job Info

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Location: East Palo Alto, CA
Description: Our client is currently seeking a Medical Specialist

Role:

• Ensure products meet regulatory requirements for safety risk management, including FDA QSR, ISO 13485, ISO 14971, and Google Health procedures.
• Collaborate with Product, Engineering, Clinical, Quality and other key functions to develop a quantitative approach to risk management.
• Providing Safety Risk Management expertise and guidance to the Post Market Surveillance Team ensuring consistent and accurate application of all Safety Risk Management standards.
• Ensure risk control measures, and key safety requirements are incorporated into the risk management planning process.
• Approving iterations to a product's Safety Risk Management Plan/ Report and hazard analyses.
• Author and/or facilitate post market risk assessment.

Responsibilities:

• Help develop and scale the activities within the Safety Risk Management lifecycle, including risk identification, assessment and control.
• Participate in the investigation and resolution of safety incidents.
• Provide safety input into design, development, test, deployment and post-market surveillance activities of all in-scope products and services.
• Assist in the safety risk rating of all current and future development.

Top 3 Daily Responsibilities:

• Providing Safety Risk Management expertise for medical device products.
• Approving iterations to a product's Safety Risk Management Plan/ Report and hazard analyses
• Ensure products meet regulatory requirements for safety risk management, including FDA QSR, ISO 13485, ISO 14971

Skill/Experience/Education

MandatoryExperience in safety risk management and risk assessment techniques Clinical qualification Registered Nurse 1-9 years experience Will also consider board certified MD of any specialty Current registration with a relevant professional body Experience with safety risk management within medical device industry Excellent domain expertise in clinical practice, clinical workflows and evidence-based medicine. Outstanding communication and interpersonal skills including the ability to be personable yet persistent Adaptable, proactive and a solid team player who can influence teams and drive decision making.

DesiredExperience working on software as a medical device and Artificial Intelligence

Contact: akumar19@judge.com

This job and many more are available through The Judge Group. Find us on the web at www.judge.com

This job has expired.