{"id":16938,"date":"2025-05-20T14:12:30","date_gmt":"2025-05-20T18:12:30","guid":{"rendered":"https:\/\/www.blackdiamondnet.com\/jobs\/remote-denovo-regulatory-consultant-237453\/"},"modified":"2025-05-20T14:12:30","modified_gmt":"2025-05-20T18:12:30","slug":"remote-denovo-regulatory-consultant-237453","status":"publish","type":"jobs","link":"https:\/\/www.blackdiamondnet.com\/it\/jobs\/remote-denovo-regulatory-consultant-237453\/","title":{"rendered":"Remote: DeNovo Regulatory Consultant (237453)"},"content":{"rendered":"<p><span style=\"text-decoration: underline;\"><strong>Job Description: <\/strong><\/span><\/p>\n<p>Our client is seeking a skilled regulatory professional with expertise in the de Novo classification \/ pathway for an IVD to provide insight for building a de novo path overview, regulatory strategy, competitive landscape, requirements, etc. one of the client\u2019s products. The product is a type of wound care related device currently submitted through a 510(k) based on predicate devices. However, the client is interested in evaluating the possibility of adding a new claim which is not yet included on any of the predicate devices on the market. The claim would relate to anti-biofilm activity. The consultant would utilize their previous experience\/expertise to create an overview of the process, a potential regulatory strategy for the pathway, help the client to build the case for de novo classification and summarize competitive landscape.<\/p>\n<p>&nbsp;<\/p>\n<p>Remote: DeNovo Regulatory Consultant (237453)<\/p>\n<p>#LI-Remote<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Remote: DeNovo Regulatory Consultant (237453) Our client is seeking a skilled regulatory professional with expertise in the de Novo classification \/ pathway for an IVD to provide insight for building a de novo path overview, regulatory strategy, competitive landscape, requirements, etc. one of the client\u2019s products. The product is a type of wound care related device currently submitted through a 510(k) based on predicate devices.<\/p>\n","protected":false},"featured_media":0,"template":"","tags":[],"service_area":[462],"location":[561],"job_status":[585],"class_list":["post-16938","jobs","type-jobs","status-publish","hentry","service_area-scienze-della-vita-e-tecnologia","location-europa-it","job_status-closed"],"acf":[],"publishpress_future_action":{"enabled":false,"date":"2026-06-14 08:03:14","action":"category","newStatus":"draft","terms":[585],"taxonomy":"job_status","extraData":[]},"publishpress_future_workflow_manual_trigger":{"enabledWorkflows":[]},"_links":{"self":[{"href":"https:\/\/www.blackdiamondnet.com\/it\/wp-json\/wp\/v2\/jobs\/16938","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.blackdiamondnet.com\/it\/wp-json\/wp\/v2\/jobs"}],"about":[{"href":"https:\/\/www.blackdiamondnet.com\/it\/wp-json\/wp\/v2\/types\/jobs"}],"wp:attachment":[{"href":"https:\/\/www.blackdiamondnet.com\/it\/wp-json\/wp\/v2\/media?parent=16938"}],"wp:term":[{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.blackdiamondnet.com\/it\/wp-json\/wp\/v2\/tags?post=16938"},{"taxonomy":"service_area","embeddable":true,"href":"https:\/\/www.blackdiamondnet.com\/it\/wp-json\/wp\/v2\/service_area?post=16938"},{"taxonomy":"location","embeddable":true,"href":"https:\/\/www.blackdiamondnet.com\/it\/wp-json\/wp\/v2\/location?post=16938"},{"taxonomy":"job_status","embeddable":true,"href":"https:\/\/www.blackdiamondnet.com\/it\/wp-json\/wp\/v2\/job_status?post=16938"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}