Director of Regulatory Affairs TeraRecon
About the Company:
TeraRecon ushered in the genre of thin-client advanced visualization for CT and MRI with the invention of the AquariusNET Server in 2001 and has since grown to be the premier provider of volumetric image management and decision support solutions. Today, TeraRecon offers its innovative and uniquely powerful visualization platform Aquarius iNtuition?. Using ordinary PCs running either a small downloadable client application or using a web browser, iNtuition leverages many powerful technologies to deliver a delightfully intuitive, automated and collaborative user experience. iNtuition is a robust and proven, yet rapidly advancing platform which is trusted by hundreds of the largest and most prestigious healthcare institutions.
TeraRecon is a privately-held company with offices in Foster City, California; Concord, Massachusetts; Tokyo, Japan; Frankfurt, Germany; Sao Paulo, Brazil; and Savona, Italy. To learn more about the company, visit us on-line at www.terarecon.com.
TeraRecon, Inc. is seeking a Director of Regulatory Affairs to be based at the company's headquarters in Foster City, California (San Francisco bay area).
Developing ongoing program of regular 510(k) filing and management to ensure a pipeline of clearances in process and timely clearance for new features.
Defining, implementing, evolving and maintaining the company's compliance policy with regards to FDA regulations relating to labeling, marketing and promotion.
Internal training, education and initiation of corrective and preventive actions relating to sales, marketing and promotion.
Maintaining awareness of applicable regulations globally, including HIPAA, HITECH, EU MDD, Brazil ANVISA, China SFDA, Australia TGA and Health Canada. Defining and implementing policies and programs to ensure regulatory compliance in all applicable markets.
Responsible for communications and issue resolution with medical device regulatory authorities. Responsible for internal regulatory signoff according to established processes (e.g. product releases, marketing material)
Qualifications and Experience:
Relevant degree (such as regulatory affairs, scientific or legal discipline).
5+ years of professional experience in FDA-regulated industry, (ideally regulated by CDRH), at the manager or director level.
Experience and knowledge of FDA inspections and enforcement policies.
Strong knowledge and awareness of current affairs in the global medical device regulatory environment required.
Must have the ability to travel to international locations. (30-50% international travel anticipated)
Compensation and Benefits: Benefits package will include medical, dental, vision, life insurance, AD&D insurance, Sect 125, 401k and short/long-term disability insurance. Competitive depending upon qualifications and experience, to include base, bonus tied to objectives, and stock options.
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