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VP Regulatory Affairs & Quality Compliance

Job ID: 825
Type: Direct Hire

SP Regulatory Affairs & Quality Assurance

 

Our client serves the medical device industry by designing, manufacturing  the most innovative medical technology in it’s class.  Our client has a diversified mix of technology that is vastly superior and is poised for exponential growth.

 

 

VP Regulatory Affairs & Quality Assurance

 

Responsibilities:

·         Provide management and leadership to the Regulatory Affairs organization in the development and implementation of regulatory strategies and processes to gain product approvals worldwide

·         Responsible for Company’s Quality Compliance to ensure compliance with regulatory agencies and all applicable standards worldwide

·         Responsible for Company’s Quality Assurance to ensure product quality and reliability to meet or exceed customer expectations and to make quality competitive advantage

·         Assist in Clinical Studies required for Regulatory Approvals, including clinical study design, data analysis, and data reduction

·         Responsible for keeping management team informed of regulatory status of products and significant regulatory issues

·         Represent the Company before regulatory authorities

·         Provide counsel, training, and interpretation of FDA and other regulatory issues to Company personnel and assist as a liaison between the Company and regulatory authorities

·         Responsible for the review and approval of promotional, advertising, and labeling items

·         Assist in the Compliance to the Medical Device Directive (MDD) in the EU, Canadian Medical Device Directive, and other regulatory agencies

Minimum Education: 

·         Bachelor’s degree, preferably in life sciences, engineering, or business

 

Requirements:

·         Minimum of 15 years progressive experience in Regulatory Affairs, Quality Assurance, and Quality Compliance

·         Prior experience with FDA in the Office of Compliance or Office of the Chief Counsel required)

·         Excellent track record for product clearances worldwide

·         Experienced in cGMP and other regulatory compliance requirements.  Experienced in regulatory filings for US (510(k), IDE and PMA) and other key countries/regions

·         Excellent communication skills, both verbal and written, and the ability to interface effectively with engineering, manufacturing, sales and marketing, and administration

·         Good conceptual, analytical, problem solving, and organizational skills

·         A “hands-on” individual who enjoys challenge, is capable and dedicated to getting the job done

·         An assertive, take-charge, proven manager with a strong results orientation, positive “can do” attitude, and a sense of urgency to get things done

·         A mature thinking and acting executive with good common sense and judgment, and a broad business perspective with outstanding administrative capabilities to build, motivate and manage a strong quality organization

·         Well-organized and accustomed to maintaining excellent records

 

The position pays a very Competitive Base + Bonus + Stock Options and Relocation is available.

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