Intellectt Inc
Regulatory Affairs Specialist – Medical Devices
Intellectt Inc, California, Missouri, United States, 65018
Regulatory Affairs Specialist – Medical Devices
Position:
Regulatory Affairs Specialist – Medical Devices Location:
California Employment Type:
Contract At Intellectt, we believe in hiring the best talent and providing them with opportunities to thrive. If you’re a
detail-oriented, compliance-focused, and proactive professional , we want to hear from you! What You'll Do: Prepare and submit global regulatory filings including 510(k)s, Technical Files, and other international submissions. Ensure compliance with FDA, EU MDR, ISO 13485, and other applicable regulatory standards. Collaborate cross-functionally with R&D, Quality, and Clinical teams to support product development and change control. Review and approve product labelling, marketing materials, and IFUs for regulatory compliance. Support regulatory inspections and audits by preparing and presenting necessary documentation. What We're Looking For: Regulatory Submission Expertise
(510(k), CE Mark, international registrations) Strong Knowledge of Global Medical Device Regulations
(FDA, EU MDR, ISO 13485) Excellent Communication & Cross-Functional Collaboration Skills Seniority level:
Associate Job function:
Manufacturing, Engineering, and Management Industries:
Medical Equipment Manufacturing, Biotechnology Research, and Pharmaceutical Manufacturing
#J-18808-Ljbffr
Position:
Regulatory Affairs Specialist – Medical Devices Location:
California Employment Type:
Contract At Intellectt, we believe in hiring the best talent and providing them with opportunities to thrive. If you’re a
detail-oriented, compliance-focused, and proactive professional , we want to hear from you! What You'll Do: Prepare and submit global regulatory filings including 510(k)s, Technical Files, and other international submissions. Ensure compliance with FDA, EU MDR, ISO 13485, and other applicable regulatory standards. Collaborate cross-functionally with R&D, Quality, and Clinical teams to support product development and change control. Review and approve product labelling, marketing materials, and IFUs for regulatory compliance. Support regulatory inspections and audits by preparing and presenting necessary documentation. What We're Looking For: Regulatory Submission Expertise
(510(k), CE Mark, international registrations) Strong Knowledge of Global Medical Device Regulations
(FDA, EU MDR, ISO 13485) Excellent Communication & Cross-Functional Collaboration Skills Seniority level:
Associate Job function:
Manufacturing, Engineering, and Management Industries:
Medical Equipment Manufacturing, Biotechnology Research, and Pharmaceutical Manufacturing
#J-18808-Ljbffr