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REGULATORY COMPLIANCE SPECIALIST

Job Field: Legal Jobs
Location: Laguna Hills, CA
Salary: $Not stated
JOB SUMMARY:
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<tr><td valign="top" width="450"><b>Regulatory Compliance SpecialistLocation: US-CA-Laguna HillsExperience (Years): ..Category: RegulatoryJob ID: 2517Pos. Type: Full Time * ClickHEREto apply for this position and begin the application process.* Refer a friend to this jobMore information about this job:Overview:Cardiac Science develops, manufactures, and markets a family of advanced diagnostic and therapeutic cardiology devices and systems, including automated external defibrillators (AEDs), electrocardiograph devices (ECGs), cardiac stress systems and treadmills, Holter monitoring systems, hospital defibrillators, cardiac rehabilitation telemetry systems, and cardiology data management systems (informatics) that connect with hospital information (HIS), electronic medical record (EMR), and other information systems. Cardiac Science is the successor to the cardiac businesses that established the trusted Burdick&reg;, HeartCentrix&reg;, Powerheart&reg;, and Quinton&reg;brands.Responsibilities:* Researches new decisions or rulings affecting the Company''s activities* Monitors operating activities and advises management of relevant regulations and their ramifications* Maintains communication with other Quinton department personnel in order to facilitate understanding of and compliance with company procedures containing regulatory requirements* Maintains communications with regulatory agencies* Provides documentation to regulatory agencies on ongoing operations or for product registrations and applications* May coordinate collection of documents for submission and analyze supporting data* Investigates problems and complaints including employee accidents (safety) and customer complaints regarding products or service* Depending on type of work assigned, may work with engineers and marketing personnel on specific product development projects* Maintains well-organized logs and records of work performed* May specialize in one or more of the following activities: complaint monitoring, clinical trial coordination, 510(k) applications, GMP compliance, regulatory data management, sterilization procedures, employee safety, and/or environmental regulation.* Comply with company policies and procedures regarding Employee health, safety, and conduct.Qualifications:* Requires a 4-year technical degree (or equivalent combination of education/training and experience)* 3-5 years related experienceEqual Opportunity Employer &ndash; M/F/V/D

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