Check with seller Associate Director, Regulatory Affairs International Rahway

  • Location: Rahway, New Jersey, United States



Job Description

Our Regulatory Affairs team brings new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance across regulatory agencies. We are an international network on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.

The Regulatory Affairs International Headquarters (RAI-HQ) R4, Associate Principle Scientist position in the Diagnostics and Devices group is a broad role encompassing all aspects of regulatory strategy including, medical device regulation, diagnostic regulation, Chemistry, Manufacturing and Controls (CMC), clinical efficacy, safety and risk management, and labeling. He/She has direct responsibility for a portfolio of products that generally ranges across all phases of development and includes life cycle management, medical devices, combination products and diagnostics. The Associate Principle Scientist reports to a Director in RAI-HQ.

The Associate Principle Scientist will have responsibility for an assigned portfolio of products. The individual will have responsibility for leading and strategically driving results on assigned products and projects through alignment and prioritization with Department management and across stakeholders.

This highly enthusiastic, self-motivated individual functions with a high degree of independence and with an enterprise mindset. They have demonstrated their ability to think laterally as well as vertically by looking at how issues potentially impact on other functional areas. Device, diagnostic, combination product, and drug development expertise is leveraged internally to provide advice to RAI HQ Liaisons and externally via committee or cross-functional or cross-divisional team representation and consultation.

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