Job Title

Job Title: Quality and Regulatory Project ManagerHave you got the right qualifications and skills for this job Find out below, and hit apply to be considered.Gabriele & Company, recruiters for manufacturing and supply chain professionals, is assisting a globally renowned, small medical device company whose products are used in nearly half of all hospitals in the US. This world leader in their market niche is seeking an exceptional Quality and Regulatory Project Manager to drive new product line initiatives.Reporting to the VP, you will spearhead the management of new product line(s). In this pivotal role, you will collaborate cross-functionally to ensure products seamlessly align with technical, regulatory, clinical, and market standards.Salary Range: $120,000 - $150,000 per year, commensurate with experience, along with a generous benefits package.Key Responsibilities:Create and manage comprehensive product/project databasesDevelop and execute strategic product line release plan(s)Work closely with Regulatory lead/Quality team, keeping stakeholders updatedLiaise across departments for regulatory documentation (domestic & international)Manage clinical/non-clinical stakeholders for product release readinessMaintain, improve and update all relevant regulatory documentation/best practicesParticipate in CAPA Review Board, recommending corrective actionsAssist with regulatory information management system, QMSR processes, new eQMSRequirements:Bachelor's degree7+ years of Quality/Regulatory Affairs experience in Medical Device industryRegulatory Affairs knowledgeQuality Management system knowledge510K submissionsClinical submissions and trials MDR (Medical Device Rugulation/Reporting)ISOEU requirements MDSAP (Medical Device Single Audit Program)Auditing experiencePlease apply or reach out if interested in this Quality and Regulatory Project Manager opportunity with a global medical device leader!