{"id":100031794,"date":"2023-12-06T09:06:05","date_gmt":"2023-12-06T09:06:05","guid":{"rendered":"https:\/\/www.nbn.org.il\/jobboard\/?post_type=job_listing&#038;p=100031794"},"modified":"2024-02-05T00:48:58","modified_gmt":"2024-02-05T00:48:58","slug":"ra-and-qa-specialist-2","status":"expired","type":"job_listing","link":"https:\/\/www.nbn.org.il\/jobboard\/?post_type=job_listing&p=100031794","title":{"rendered":"Regulatory Affairs and Medical Device QA Specialist"},"content":{"rendered":"<pre style=\"text-align: center\">This is an NBN Connect post on behalf of another organization.<\/pre>\n<p>We are hiring an RA and QA specialist with some FDA-related experience:<\/p>\n<ul>\n<li>Class two medical device.<\/li>\n<li>Surgical robotics system and imaging.<\/li>\n<li>Full-time or part-time (flexible commuting hours).<\/li>\n<li>Located in Har Hotzvim, Jerusalem.<\/li>\n<\/ul>\n<p>The RA and QA specialist will be handling the Regulatory Affairs and Quality Assurance in the organization.<\/p>\n<p><strong>Roles and Responsibilities:<\/strong><\/p>\n<ul>\n<li>Prepare QA procedures.<\/li>\n<li>Prepare post-marketing reports.<\/li>\n<li>Manage design validation &amp; verification, and design history files.<\/li>\n<li>Follow regulatory pathways and regulatory plans.<\/li>\n<li>GAP analysis for new standards\/guidance documents.<\/li>\n<li>Prepare annual management reviews.<\/li>\n<li>Liaise with regulatory bodies (FDA, NB, etc.)<\/li>\n<li>Preparation of regulatory files (EU Technical Files, FDA submissions, etc.)<\/li>\n<li>Ensure documents comply with current regulations and regulatory guidance.<\/li>\n<li>Familiar with quality management systems including 21 CFR 820, ISO 13485 (2016), MDD &amp; CE marking, and MDSAP.<\/li>\n<li>Manage the quality-related activities. (ECO, MRB, CAPA, training, and qualifications. Internal and external Audits)<\/li>\n<li>Provide regulatory strategic direction on projects\/products<\/li>\n<\/ul>\n<p><strong>Skills and Requirements:<\/strong><\/p>\n<ul>\n<li>Excellent oral and written communication skills in English.<\/li>\n<li>Bachelors in sciences (or higher) or engineering.<\/li>\n<li>At least two years of experience in RA&amp;QA.<\/li>\n<li>Self-learner and team player.<\/li>\n<\/ul>\n","protected":false},"author":38,"featured_media":100027681,"template":"","meta":{"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"_promoted":"","_job_location":"","_application":"resumes@nbn.org.il","_company_name":"NBN Recruitment Services","_company_website":"","_company_tagline":"","_company_twitter":"","_company_video":"","_filled":0,"_featured":0,"_remote_position":0,"_job_salary":"","_job_salary_currency":"","_job_salary_unit":""},"job_listing_region":[44],"job-categories":[107,164],"job-types":[2,3],"class_list":{"0":"post-100031794","1":"job_listing","2":"type-job_listing","3":"status-expired","4":"has-post-thumbnail","5":"hentry","6":"job_listing_region-jerusalem","7":"job_listing_category-hi-tech","8":"job_listing_category-quality-assurance","9":"job_listing_type-full-time","10":"job_listing_type-part-time","12":"job-type-full-time","13":"job-type-part-time"},"_links":{"self":[{"href":"https:\/\/www.nbn.org.il\/jobboard\/wp-json\/wp\/v2\/job-listings\/100031794","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.nbn.org.il\/jobboard\/wp-json\/wp\/v2\/job-listings"}],"about":[{"href":"https:\/\/www.nbn.org.il\/jobboard\/wp-json\/wp\/v2\/types\/job_listing"}],"author":[{"embeddable":true,"href":"https:\/\/www.nbn.org.il\/jobboard\/wp-json\/wp\/v2\/users\/38"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.nbn.org.il\/jobboard\/wp-json\/wp\/v2\/media\/100027681"}],"wp:attachment":[{"href":"https:\/\/www.nbn.org.il\/jobboard\/wp-json\/wp\/v2\/media?parent=100031794"}],"wp:term":[{"taxonomy":"job_listing_region","embeddable":true,"href":"https:\/\/www.nbn.org.il\/jobboard\/wp-json\/wp\/v2\/job_listing_region?post=100031794"},{"taxonomy":"job_listing_category","embeddable":true,"href":"https:\/\/www.nbn.org.il\/jobboard\/wp-json\/wp\/v2\/job-categories?post=100031794"},{"taxonomy":"job_listing_type","embeddable":true,"href":"https:\/\/www.nbn.org.il\/jobboard\/wp-json\/wp\/v2\/job-types?post=100031794"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}