What are the responsibilities and job description for the Clinical Regulatory and Quality manager (Boston, MA) position at CEDENT?
Position: Clinical, Regulatory, and Quality Manager
??"?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
??"?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