Risk Manager
4 weeks ago
You are responsible for
Ensuring the Policy for Establishing Safety Risk Acceptability for the product is created, approved, and maintained by top management.
Ensures product safety risk management deliverables are created, maintained, and stored in the Risk Management file during product development.
Monitors and reports on the product’s safety risk management performance in the field and ensures deliverables are updated as needed. Ensures the appropriate risk assessments are performed when triggers are met.
Represent Risk Management and design quality activities during external and internal audits.
Perform periodic reviews of Risk Management Files and ensure those are performed according to schedule.
Monitor post product data (e.g. Complaints, Corrective and Preventive Actions (CAPA), Non-conformance Reports (NCRs), Customer Feedback information, etc.) for impact to the Risk Management Files.
Coordinates with a cross functional team including Engineering and Medical Affairs in the creation and maintenance of the deliverables listed above.
In this role, you should have the following skills and experience
Bachelor’s degree, Engineering or Science discipline preferred or equivalent work experience
5-10 years working experience in a regulated industry specially software as a medical device.
5+ years working experience in product development or post-market surveillance, system engineering experience.
Strong Experience in execution of risk management activities and deliverables.
Knowledge of ISO14971 and product specific regulations and standards specifically in software domain (IEC 62304)
Clinical knowledge highly desired.
Ability to work with multisite teams.
Proactive and self-driven.
Your skills should include high-level writing skills and acute attention to detail. Excellent interpersonal and problem-solving skills; passion for clinical safety, quality, and innovation.
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