Thanks to former JETAA Minnesota officer Errol Packard for sharing this JET-relevant job listing.
Posted by Kay Monroe (Miyazaki-shi, 1995 -97). Click here to join the JETwit Jobs Google Group and receive job listings even sooner by email.
Position: Regulatory Affairs Specialist
Posted by: Cook Medical
Location: Bloomington, IN
Start Date: N/A
The Regulatory Affairs Specialist responsibilities are narrowly focused to a specific country and/or region in which the Specialist has proficient language skills (reading/writing/speaking). The Regulatory Specialist helps develop regulatory strategies, obtain and maintain approval, and serve as a communication liaison between the Cook manufacturer and the Cook International Local Office and/or Cook Distributor.
• Serves as a liaison on regulatory issues between the Cook manufacturer and the Cook International Local Office and/or Cook Distributor
• Communicates country/region-specific regulatory requirements to the Regulatory Specialist/Regulatory Science team leaders and assists with the regulatory strategies
• Plans and prepares regulatory submissions for new products, product changes, and re-registrations as required for the specific countries/regions
• Maintains registration information (license numbers, expiration dates, etc.) and obtains re-registration approvals in advance of license expirations to ensure no disruption in product availability
• May communicate directly with the regulatory authorities to ensure product approvals are achieved in a timely manner
• Performs translation activities as needed
•Collaborates with Regulatory Scientific Affairs on all high risk devices and new technologies
•Collaborates with the Clinical Functional Unit on projects requiring the collection of clinical data
•Provides support to currently marketed products as necessary including input on change requests, etc.
•Maintains and organizes appropriate regulatory records to demonstrate compliance with applicable regulations
•Must work effectively with and for others to achieve company goals
•Must strictly adhere to safety requirements
• Maintain regular and punctual attendance
•Must maintain company quality standards
Desired Skills & Experience
•Proficient in reading, writing and speaking Japanese
• 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
Since 1963, Cook Group companies have been among the leaders in developing healthcare devices that have improved lives around the world. Cook is at the forefront of medical research and global sales of products for endovascular therapy, critical care medicine, general surgery, diagnostic and interventional procedures, bioengineered tissue replacement and regeneration, gastroenterology and endoscopy procedures, urology, and obstetrics and gynecology.