Regulatory Affairs Specialist – Medical Devices

Intellectt Inc; California; Presencial; USD 60.000 - 100.000; Jornada completa

Descripción de la vacante

A forward-thinking company is seeking a Regulatory Affairs Specialist with a strong focus on compliance and detail. In this exciting role, you will prepare and submit global regulatory filings, ensuring adherence to FDA, EU MDR, and ISO 13485 standards. You will collaborate with cross-functional teams to support product development and regulatory inspections. This position offers the opportunity to make a significant impact in the medical devices sector, working within a dynamic team dedicated to innovation and excellence. If you are proactive and passionate about regulatory affairs, this is the perfect opportunity for you.

Formación

• Detail-oriented professional with expertise in regulatory submissions.
• Strong knowledge of FDA, EU MDR, and ISO 13485 regulations.

Responsabilidades

• Prepare and submit global regulatory filings including 510(k)s and Technical Files.
• Ensure compliance with FDA and international regulatory standards.

Conocimientos

Regulatory Submission Expertise

Knowledge of Global Medical Device Regulations

Communication Skills

Cross-Functional Collaboration Skills

Descripción del empleo

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