Cedent Consulting
Position:
Clinical, Regulatory, and Quality Manager Location:
Boston, MA (Onsite)
What You'll Do:
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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Clinical, Regulatory, and Quality Manager Location:
Boston, MA (Onsite)
What You'll Do:
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
#J-18808-Ljbffr