{"id":1251,"date":"2022-09-20T16:50:26","date_gmt":"2022-09-20T23:50:26","guid":{"rendered":"https:\/\/shapememordev.wpenginepowered.com\/japan\/?page_id=1251"},"modified":"2023-02-10T15:37:00","modified_gmt":"2023-02-10T23:37:00","slug":"regulatory-affairs-specialist","status":"publish","type":"page","link":"https:\/\/www.shapemem.com\/japan\/regulatory-affairs-specialist\/","title":{"rendered":"Regulatory Affairs Specialist"},"content":{"rendered":"<div class=\"wpb-content-wrapper\"><p>[vc_section nav_skin=&#8221;light&#8221;][vc_row nav_skin=&#8221;light&#8221; consent_include=&#8221;include&#8221;][vc_column css_animation=&#8221;&#8221;][vc_text_element css_animation=&#8221;&#8221;]<\/p>\n<h2 id=\"yui_3_17_2_1_1649782806974_153\">Regulatory Affairs Specialist<\/h2>\n<p>[\/vc_text_element][vc_text_element css_animation=&#8221;&#8221;]<\/p>\n<h5>About the job<\/h5>\n<p>Plan, manage, and implement processes to ensure compliance with applicable regulatory requirements.\u00a0 Interface with FDA, Notified Body, and other Regulatory Agencies.\u00a0 Aid in regulatory strategy decisions.\u00a0 Provide input on regulatory requirements for new product development or design\/process change projects. Oversee device registrations, listings, certifications, and technical documentation.<\/p>\n<h5>Essential duties and responsibilities<\/h5>\n<ul>\n<li>Provide support for the regulatory department to ensure efficient and compliant processes<\/li>\n<li>Execute tasks and partner across business functions<\/li>\n<li>Assist in SOP development and review<\/li>\n<li>Participate in worldwide regulatory submissions<\/li>\n<li>Review promotional and advertising materials to provide regulatory compliance input and ensure that they are effectively presented to substantiate claims<\/li>\n<li>Provide regulatory input to product lifecycle planning<\/li>\n<li>Assist in the development of regional regulatory strategy<\/li>\n<li>Understand, investigate and evaluate applicable regulations in order to assess regulatory implications for approval<\/li>\n<li>Determine and communicate submission and approval requirements<\/li>\n<li>Compile, prepare, review and submit regulatory submissions to authorities<\/li>\n<li>Evaluate proposed preclinical, clinical, and manufacturing changes for regulatory filing strategies<\/li>\n<li>Assist compliance with product post-marketing approval requirements<\/li>\n<\/ul>\n<h5>Education, experience, and skills required<\/h5>\n<ul>\n<li>B.S. or M.S. in law, medicine, pharmacy, engineering, or another relevant scientific discipline<\/li>\n<li>Six or more years experience in medical devices<\/li>\n<li>One year of professional experience in regulatory affairs or in quality management systems relating to medical devices<\/li>\n<li>Experience with regulatory submissions (i.e. 510K, De Novo, PMA, EU Notified Body, Japan PMDA)<\/li>\n<li>Excellent writing skills<\/li>\n<li>Ability to organize and prioritize work and to meet deadlines<\/li>\n<\/ul>\n<h5><span style=\"font-size: 18px; letter-spacing: -0.04em;\">Physical demands<\/span><\/h5>\n<p>The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.\u00a0 Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.\u00a0 While performing the duties of this job, the employee is regularly required to stand; walk, and sit for extended periods of time.\u00a0 Occasionally the employee will be required to lift or move at least 50 pounds.<\/p>\n<h5>To\u00a0 Apply<\/h5>\n<p>Interested candidates should submit their resume to <a href=\"mailto:careers@www.shapemem.com\">careers@www.shapemem.com<\/a> with the job title as the subject.<br \/>\nResumes from recruiters will not be accepted.[\/vc_text_element][\/vc_column][\/vc_row][\/vc_section]<\/p>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>[vc_section nav_skin=&#8221;light&#8221;][vc_row nav_skin=&#8221;light&#8221; consent_include=&#8221;include&#8221;][vc_column css_animation=&#8221;&#8221;][vc_text_element css_animation=&#8221;&#8221;] Regulatory Affairs Specialist [\/vc_text_element][vc_text_element css_animation=&#8221;&#8221;] About the job Plan, manage, and implement processes to ensure compliance with applicable regulatory requirements.\u00a0 Interface with FDA, Notified Body, and other Regulatory Agencies.\u00a0 Aid in regulatory strategy decisions.\u00a0 Provide input on regulatory requirements for new product development or design\/process change projects. Oversee device registrations, listings, certifications, and technical documentation. Essential duties and responsibilities Provide support for the regulatory department to ensure efficient and [&hellip;]<\/p>\n","protected":false},"author":5,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"class_list":["post-1251","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Regulatory Affairs Specialist - Shape Memory Medical - Japan<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.shapemem.com\/japan\/regulatory-affairs-specialist\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Regulatory Affairs Specialist - Shape Memory Medical - Japan\" \/>\n<meta property=\"og:description\" content=\"[vc_section nav_skin=&#8221;light&#8221;][vc_row nav_skin=&#8221;light&#8221; consent_include=&#8221;include&#8221;][vc_column css_animation=&#8221;&#8221;][vc_text_element css_animation=&#8221;&#8221;] Regulatory Affairs Specialist [\/vc_text_element][vc_text_element css_animation=&#8221;&#8221;] About the job Plan, manage, and implement processes to ensure compliance with applicable regulatory requirements.\u00a0 Interface with FDA, Notified Body, and other Regulatory Agencies.\u00a0 Aid in regulatory strategy decisions.\u00a0 Provide input on regulatory requirements for new product development or design\/process change projects. 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