Clinical Regulatory and Quality manager (Boston, MA)

mid

OtherQuality Manager

0 views0 saves0 applied

Apply Now

Quick Summary

Overview

function googleTranslateElementInit() { new google.translate.TranslateElement({pageLanguage: 'en'}, 'google_translate_element'); } Clinical Regulatory and Quality manager (Boston, MA)…

Key Responsibilities

Lead Clinical Research, Regulatory Affairs, and Quality Management, including: ??"? Overseeing FDA submissions (510(k), De Novo, PMA) ??"? Developing SOPs and building a scalable QMS ??"?

Requirements Summary

? 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 ?

Technical Tools

healthtech

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

Visit Careers at CEDENT

Subscribe to be notified of new jobs

If we don't have an open position that fits you, feel free to subscribe to our Talent Team email! Enter your name, email address and position(s) you're interested in, and whenever we open a new position matching your criteria we'll notify you immediately.