Director, Regulatory Affairs - GMP, 510K, Labeling

Company Name:
CLEAR Management Solutions
We are working on an immediate opportunity in the Rochester, NY area for a Director of Regulatory Affairs. This position supports strategic planning and management for the execution of comprehensive programs related to regulatory clearances, controls, and the assurance of corporate compliance with applicable U.S. and international medical device regulations and standards.
Responsibilities include but are not limited to:
o Create strategy and perform oversight for global commercialization and post-market regulatory activities.
o Establish and implement regulatory policies and procedures.
o Supervision of global Regulatory Affairs professionals to assure effective compliance to corporate regulatory policies and procedures.
o Represent the company with US FDA, other government entities, regulatory professionals, consultants, and trade associations regarding regulated activities.
o Provide regulatory guidance on developing, conducting and monitoring of clinical investigations.
o Partner with business groups to monitor and maintain a compliant Quality Management System.
o Review changes to existing products' designs, materials and manufacturing processes to determine when notification to, or approval by, domestic and international authorities are required.
o Review and approve customer publications, labels, labeling and marketing advertising and/or promotional materials for products marketed by the company.
Required skills, education and experience includes:
o BS in a scientific, clinical or other technical discipline. Ideal is Regulatory Affairs
o Regulatory experience (7 years) in a medical device, medical software or pharmaceutical company. Duties should have included exercise of considerable independent judgment in the performance of assigned duties.
o Experience (7 years) with applicable US Drug and Device regulations: FDA 510(K) and PMA clearances, GMPs, Labeling requirements.
o Demonstrated 3 years team leadership - interpersonal skills, development of personnel and effective teams.
o 3 years of strong technical writing skills-will ask for samples of writing.
o 2 years of experience interacting with FDA.
o Knowledge of Global regulations is a plus; EU Medical Device Directive and standards is a plus.
o Ability to handle simultaneous tasks and prioritize accordingly.
o Demonstrates excellent written, oral, technical and interpersonal communication skills with personnel at all levels.
o Exhibits a high degree of integrity, initiative, motivation and analytical skills.
To explore this opportunity further please contact:
Rob Lyon
CLEAR Management Solutions
West (408) 484-6266
East (603) 888-3466
Main (866) 952-8855

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