{"id":27090,"date":"2012-09-19T16:40:31","date_gmt":"2012-09-19T20:40:31","guid":{"rendered":"http:\/\/jetwit.com\/wordpress\/?p=27090"},"modified":"2012-09-19T16:41:15","modified_gmt":"2012-09-19T20:41:15","slug":"job-regulatory-affairs-specialist-japanese-language-bloomington-in","status":"publish","type":"post","link":"https:\/\/jetwit.com\/wordpress\/2012\/09\/19\/job-regulatory-affairs-specialist-japanese-language-bloomington-in\/","title":{"rendered":"Job: Regulatory Affairs Specialist (Japanese language) (Bloomington, IN)"},"content":{"rendered":"

Thanks to former JETAA Minnesota officer Errol Packard<\/strong> for sharing this JET-relevant job listing<\/em>.
\nPosted by <\/em>Kay Monroe<\/a> (Miyazaki<\/a>-shi, 1995 -97)<\/em><\/strong>. Click here<\/a> to join the JETwit Jobs Google Group<\/a> and receive job listings even sooner by email.<\/em>
\n\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014
\nPosition<\/em><\/strong>: <\/em>Regulatory Affairs Specialist<\/em>
\nPosted by<\/strong>: <\/em>\u00a0Cook Medical<\/em>
\nType<\/em><\/strong>: <\/em>Full-time<\/em>
\nLocation<\/strong>: <\/em><\/em>Bloomington, IN<\/em><\/em>
\nSalary<\/strong>: N\/A<\/em>
\nStart Date<\/strong>: N\/A<\/em><\/em><\/strong><\/em><\/p>\n

Job Description:<\/strong>
\nThe 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.<\/p>\n

\u2022 Serves as a liaison on regulatory issues between the Cook manufacturer and the Cook International Local Office and\/or Cook Distributor
\n\u2022 Communicates country\/region-specific regulatory requirements to the Regulatory Specialist\/Regulatory Science team leaders and assists with the regulatory strategies
\n\u2022 Plans and prepares regulatory submissions for new products, product changes, and re-registrations as required for the specific countries\/regions
\n\u2022 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
\n\u2022 May communicate directly with the regulatory authorities to ensure product approvals are achieved in a timely manner
\n\u2022 Performs translation activities as needed
\n\u2022Collaborates with Regulatory Scientific Affairs on all high risk devices and new technologies
\n\u2022Collaborates with the Clinical Functional Unit on projects requiring the collection of clinical data
\n\u2022Provides support to currently marketed products as necessary including input on change requests, etc.
\n\u2022Maintains and organizes appropriate regulatory records to demonstrate compliance with applicable regulations
\n\u2022Must work effectively with and for others to achieve company goals
\n\u2022Must strictly adhere to safety requirements
\n\u2022 Maintain regular and punctual attendance
\n\u2022Must maintain company quality standards<\/p>\n

Desired Skills & Experience<\/strong>
\n\u2022Proficient in reading, writing and speaking Japanese
\n\u2022 Bachelor\u2019s 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<\/p>\n

Company Description<\/strong>
\nSince 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.<\/p>\n","protected":false},"excerpt":{"rendered":"

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. \u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014 Position: Regulatory Affairs Specialist Posted by: \u00a0Cook Medical Type: Full-time Location: Bloomington, IN Salary: N\/A Start […]<\/p>\n","protected":false},"author":85,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"jetpack_post_was_ever_published":false,"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[3],"tags":[],"class_list":["post-27090","post","type-post","status-publish","format-standard","hentry","category-jobs"],"aioseo_notices":[],"jetpack_publicize_connections":[],"jetpack_featured_media_url":"","jetpack_shortlink":"https:\/\/wp.me\/pkZ7m-72W","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/jetwit.com\/wordpress\/wp-json\/wp\/v2\/posts\/27090","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/jetwit.com\/wordpress\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/jetwit.com\/wordpress\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/jetwit.com\/wordpress\/wp-json\/wp\/v2\/users\/85"}],"replies":[{"embeddable":true,"href":"https:\/\/jetwit.com\/wordpress\/wp-json\/wp\/v2\/comments?post=27090"}],"version-history":[{"count":3,"href":"https:\/\/jetwit.com\/wordpress\/wp-json\/wp\/v2\/posts\/27090\/revisions"}],"predecessor-version":[{"id":27093,"href":"https:\/\/jetwit.com\/wordpress\/wp-json\/wp\/v2\/posts\/27090\/revisions\/27093"}],"wp:attachment":[{"href":"https:\/\/jetwit.com\/wordpress\/wp-json\/wp\/v2\/media?parent=27090"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/jetwit.com\/wordpress\/wp-json\/wp\/v2\/categories?post=27090"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/jetwit.com\/wordpress\/wp-json\/wp\/v2\/tags?post=27090"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}