Device CMC Manager for Regulatory Affairs

Lead global regulatory strategies as a Device CMC Manager, focusing on combination devices and ensuring compliance. This crucial role supports the preparation of regulatory documentation for development and marketed products.

In this leadership role, you will contribute to the formulation of global regulatory device strategies for commercial products. Your expertise will help guide cross-functional teams through the intricacies of compliance with various regulatory standards. Emphasis will be placed on collaboration and strategic problem-solving to navigate complex regulatory landscapes.

Key Responsibilities:

• Review regulatory submissions for device sections

• Develop global regulatory device strategies

• Collaborate on drug device CMC submissions

• Provide guidance on compliance topics

• Assess regulatory issues and support investigations

Requirements:

• Strong interpersonal communication skills

• Proficient in FDA, EMA, ICH regulations

• Experience in drug device CMC submissions

• Strategic thinking and problem-solving capabilities

• Bachelor’s degree in relevant life sciences

Utilize your regulatory expertise to guide device strategies and support product compliance in a global marketplace.
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