Company OverviewMedical Devices
Job DescriptionPosition provides regulatory expertise for the site. The incumbent will also be required to provide regulatory advice and assistance to other Medical site representatives. This will require travel from time to time to effectively carry out these duties.
• Prepare and submit regulatory application and STED to PMDA and RCB as directed.
• Review and approve Pre-launch product submissions to ensure compliance with internal company requirements and compliance with regulatory requirements.
• Review and provide oversight of Global Product Registration in support of Direct Reports.
Requirements• Bachelor's degree in Science or Engineering (or related field) from an accredited college or university is preferred. A minimum of Seven to ten years direct experience in quality/regulatory affairs (preferably in the medical device/drug or biomedical area).
• Excellent working knowledge of up-to-date domestic, international, and company regulatory compliance requirements and operating procedures. Including but not limited to FDA, PMAA, IDE, 510(k) Notifications, Medical Device Directive, and European Standards.
• Sound knowledge and understanding of how clinical studies are performed.
• Ability to negotiate critical points regarding devices to the favor of corporate objectives, (i.e. to reduce costs associated with regulation and/or marketing
• Ability to analytically assimilate regulatory information and updates and effectively convey these principals to appropriate departments.