Regulatory Manager / Senior Regulatory Manager

March 29

pfm medical, inc.

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pfm medical, Inc. is a subsidiary of pfm medical ag (Cologne, Germany) and was established in 2001 to serve as headquarters for North, Central, and South American development, manufacturing, marketing, and distribution activities$1. .$1

Medical Device Manufacturing

11 - 50

Description

• Provide regulatory strategy and development guidance for clinical trials • Coordinate and prepare regulatory documents for submissions • Maintain current knowledge of regulations and guidance documents • Support and enhance corporate Regulatory function • Assist in development and approval of new study opportunities • Participate in maintaining and executing corporate quality initiatives

Requirements

• Bachelor's degree, preferably in a scientific or healthcare discipline • 5 years Regulatory experience required for the Manager level • 7 years Regulatory experience required for the Senior Manager Regulatory level • Computer literacy (MS Office/ Office 365) • Fluent in English • Regulatory affairs experience working for a Clinical Research Organisation • Experience leading Clinical Submissions • Understanding of drug development process and regulatory milestones • Availability for domestic and international travel

Benefits

• Competitive salary • Career progression opportunities • Flexible work arrangements • International travel opportunities