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Director Of Regulatory Affairs

Location: PA
Industry: Medical Device
Job Code: 12024-08

Description:

• Provide continuous regulatory support and information during development and production for products or services that are regulated by the FDA to assure both regulatory and customer expectations are met.
• Development, implementation and coordination of regulatory strategy based on current regulations, in-dustry best practices and the impact on company products and processes.
• Shared responsibility for the submission of Medical device submissions; 510(k)s, Technical Files (Design Dossiers)
• Formulate partnering initiatives with internal and external customers to develop, implement and expedite regulatory processes with global regulatory agencies

Qualifications:

• B.S. Required. Advanced degree preferred.
•At least 10 years hand on experience in regulatory affairs with several years leading, managing and mentoring other regulatory affairs professionals
• At least 5 years in management with direct communication/interaction with regulatory agencies, (eg. FDA)
• Experience in preparation, submission and maintenance of regulatory submissions; 510(k)s, Technical Files (Design Dossiers), Design History Files, Device Master Records, Combination Products, etc.
• Extensive knowledge of U.S. & Canadian, and European regulations, cGMPs, QSRs, validation requirements, etc.
• Regulatory experience with a medical device or large pharmaceutical company, or experience as a supplier to the in-dustry; with extensive knowledge of pharmaceutical and/or medical device products
• Strong leadership experience is required

 

CONTACT:

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