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

• Provides regulatory guidance throughout the clinical development life cycle • Compile, coordinate and review applications to Regulatory Authorities • Develops and/or reviews documents intended for submission to Regulatory Authorities • Serve as representative of Global Regulatory Affairs at project team meetings • Works within a project team, and where necessary, leads project for the region or globally • Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets • Maintain project plans, project trackers and regulatory intelligence tools • Provide input into regulatory strategy and timeline development • Participate in maintaining and executing corporate quality initiatives • Keep abreast and expand knowledge of laws, regulations and guidelines governing drug development and approval • Provide ICH GCP guidance, advice and training • Serve as representative of Global Regulatory Affairs at business development meetings

Requirements

• Bachelor's degree, ideally in a scientific or healthcare discipline • 5 years Regulatory experience required for Manager level, 7 years for 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 • Ability to understand clinical and pre-clinical study results • Knowledgeable of clinical trials methodology • Knowledge and expertise with relevant regulations and guidance • Availability for domestic and international travel

Benefits

• Competitive salary • Potential for career growth • Opportunities for domestic and international travel • Training and development programs