RA Regulatory Affairs MANAGER, Medical Devices AZ

Our client is a global leader in developing, manufacturing, and marketing of innovative medical devices in the fields of Vascular, Oncology, Urology, and Surgical products. We are pleased to be involved with the search for Regulatory Affairs Program Manager for this company dedicated to pursuing technological innovations at reduced overall costs that offer superior clinical benefits

RA Regulatory Affairs Program Manager
Manages the domestic (U.S.) and international activities of related product lines for the Regulatory Affairs department according to
• corporate procedures and policies
• U.S. Government policies, the Food and Drug Administration (FDA); applicable State requirements; and European and international regulations and standards.
• Coordinates domestic and international submission preparation and approval in a timely manner according to policy and procedures.
Responsible for determining RA strategies for products.
Recognize potential regulatory issues in day-to-day activities that involve product development through the manufacturing process.

Responsibilities
• Supervisory responsibilities for direct reports, hiring, performance, salaries development, training.
• Responsible regulatory issues of product lines and assures product is in compliance with all internal and external regulatory requirements.
• Develop, document and implement regulatory submission plans around product development/line extension goals. Prepares U.S. FDA 510(k), IDE, PMA and export submissions as required.
• Ensures that all submissions are accurate, appropriate defendable and scientifically sound and completed in a timely manner. Including preparing and updating European and international product dossiers/registrations as required.
• Provides labeling, recall and FDA inspection assistance ensuring compliance with PMA change control and reporting requirements.
• Reviews Engineering Change Orders for compliance with FDA, European and international regulations and standards.
• Reviews all clinical and marketing study protocols for compliance with FDA, European and international regulations and standards.
• Reviews Engineering Change Orders for compliance with FDA, European and international regulations and standards.
Requirements
• Bachelor's Degree in Life or Engineering Science
• Six to eight years experience in a Regulatory Affairs function with three years of supervisory experience
• Functions well individually as well as participating in and leading a cross-functional team environment in the technical and supervisory capacities.
• Comprehensive knowledge of U.S., European and international regulations and standards covering medical devices.
• Knowledge related to clinical application of medical devices.

Prefer RAC certification
• Excellent analytical, negotiation and communication (computer, verbal and written) skills.

Shore Consultants is the fastest growing most comprehensive Pharmaceutical /Medical Device Recruiting Firm within the MRI Network. Why? We deliver over and over and over; one quality placement at a time. MRI is the largest search and recruitment organization in the world today. Come and see the ultimate standard in client and candidate satisfaction. Visit www.sceaston.com for client critical information and exciting new careers!!!
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Key words; ISO 14385 Quality Assurance, Implantable, Surgical, Vascular, OR, 510(k), RA, Surgery, QA, QC, Complaints, RAPS,


REQUIREMENTS
Please see Job Description