CEDENT
Clinical Regulatory and Quality manager (Boston, MA)
CEDENT, Boston, Massachusetts, us, 02298
Position: Clinical, Regulatory, and Quality Manager
Make your application after reading the following skill and qualification requirements for this position. ??"?Location: Boston, MA (Onsite)
What You'll Do: Lead Clinical Research, Regulatory Affairs, and Quality Management, including:
??"? Overseeing FDA submissions (510(k), De Novo, PMA) ??"? Developing SOPs and building a scalable QMS ??"? Managing design documentation control for product development ??"? Leading quality audits and fostering team growth
Who You Are: ? 3-5 years of experience in Clinical, Regulatory, and Quality roles within medical devices or healthtech ? Strong knowledge of FDA processes, ISO 13485, and clinical trial design ? Experience in a startup environment, thriving in dynamic challenges ? SaMD familiarity ? Bonus: Regulatory Affairs Certification (RAC), CQA, or Six Sigma
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Make your application after reading the following skill and qualification requirements for this position. ??"?Location: Boston, MA (Onsite)
What You'll Do: Lead Clinical Research, Regulatory Affairs, and Quality Management, including:
??"? Overseeing FDA submissions (510(k), De Novo, PMA) ??"? Developing SOPs and building a scalable QMS ??"? Managing design documentation control for product development ??"? Leading quality audits and fostering team growth
Who You Are: ? 3-5 years of experience in Clinical, Regulatory, and Quality roles within medical devices or healthtech ? Strong knowledge of FDA processes, ISO 13485, and clinical trial design ? Experience in a startup environment, thriving in dynamic challenges ? SaMD familiarity ? Bonus: Regulatory Affairs Certification (RAC), CQA, or Six Sigma
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