Global Medical Device Regulatory Specialist (Contract)

Intellectt Inc; California; Presencial; USD 60 000 - 100 000; Tempo integral

Resumo da oferta

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.

Qualificações

• 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.

Conhecimentos

Regulatory Submission Expertise

Knowledge of Global Medical Device Regulations

Communication Skills

Cross-Functional Collaboration Skills

Descrição da oferta de emprego

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.