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Director of Regulatory

Location: Pittsburgh, PA
Job Type: Direct Hire
Salary: $130,000.00 - $155,000.00
Degree: Doctor of Philosophy; Bachelor of Science; Master of Science;
Date: 2/15/2018
Job ID: 02570193
Job Description
Director of Regulatory and Clinical Operations

The ideal candidate will take on the following tasks:
·        Contribute to the strategic planning of the company’s regulatory affairs
·        Lead the implementation of the company’s regulatory strategy and provide evidence-based opinions and advice 
·        Manage all relations with FDA and 510k submission
·        Provide management with continuous input on regulatory matters and their interactions with business development, clinical development, commercialization, financial planning, manufacturing, and execution.
·        Manage day–to–day activities of regulatory consultants

The ideal candidate will possess the following qualities:
·        Experience developing at least 2  Class II medical devices from prototype-phase, pre-FDA approval to post-FDA approval commercialization 
·        Strong project planning and management skills, coupled with strong leadership skills and ability to drive results
·        Strong networking skills with solid record of maintaining and developing successful relationships with opinion leaders and investigators 
·        Strong conceptual thinking and innovative skills and ability integrate input from diverse fields of research and development
·        Advanced scientific knowledge in the area of neurology, digital signal processing, data science, clinical relations, or experimental trial design a plus

The Butlers Company • 2451 McMullen Booth Rd. • Oakbrook Tower • Suite 200 • Clearwater, FL 33759
Phone: 727.725.1065 • Fax: 727.725.0389 •