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In an environment where medical product regulations seem to be expanding continuously, proportional investment in compliance infrastructure and controls runs the risk of diminishing returns. The key to achieving the right balance of commercial success and compliance is to focus on continuous improvement, specifically root-cause analysis.
The US Food and Drug Administration (FDA) has published a new draft guidance intended to assist industry with developing products under the agency's so-called "Animal Rule," a regulatory pathway intended to facilitate approvals of medical countermeasures to rare, emerging or serious pathogens.
The Regulatory Affairs Specialist II responsibilities are narrowly focused to a specific country and/or region in which the Specialist has proficient language skills in the Korean language (reading/writing/speaking). This position requires the ability to speak, read and write in business level region specific language for purposes of communicating with regulatory authorities and international local Cook offices or distributors. The Regulatory Affairs Specialist II develops regulatory strategies, obtains and maintains approvals, and serves as a communication liaison between the Cook manufacturer and the Cook International Local Office / Cook Distributor.
• Communicate and interface directly with regulatory authorities to ensure product approvals are achieved in a timely manner • Communicate Country/region-specific regulatory requirements to the Regulatory Specialist/Regulatory Science team leaders and assist with the regulatory strategies • Develop regulatory strategies, obtain and maintain product approval, and serve as a communication liaison on regulatory issues between the Cook manufacturer and the Cook International Local Office and/or Cook Distributor • Plan and prepare regulatory submissions for new products, product changes, and re-registrations as required for the specific countries/regions • Maintain registration information (license numbers, expiration dates, etc.) and obtain re-registration approvals in advance of license expirations to ensure no disruption in product availability • Perform translation activities • Collaborate with Regulatory Scientific Affairs on all high risk devices and new technologies
• Collaborate with the Clinical Functional Unit on projects requiring the collection of clinical data • Provide support to currently marketed products as necessary including input on change requests, etc. • Maintain and organize appropriate regulatory records to demonstrate compliance with applicable regulations • Must work and interact effectively and professionally with and for others throughout various levels of the global organization • Must strictly adhere to safety requirements • Maintain regular and punctual attendance • Must maintain company quality and quantity standards • Must have effective oral and written communication skills • Excellent problem solving skills and ability to work in collaborative and independent work situations and environments with minimal supervision • Ability to remain calm and receptive in fast paced situations
• General office environment • Sits for extended periods • Requires close visual acuity when working with computers, etc. • Requires occasional early morning or late evening teleconferences • International and domestic travel as required
• Proficient in reading, writing and speaking region specific language(s), Korean • Bachelor’s degree in a life science (preferably biology or chemistry), engineering, or other related field (such as law); or experience of such kind and amount as to provide a comparable background