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Health Care/Attorney/In House/Menlo Park, California

Menlo Park CA Senior Managing / Principal Engineer/Scientist - Regulatory, Biomedical Engineering The candidate will manage and execute complex projects related to preclinical strategy and all phases of the FDA product review and approval process of medical devices in support of clients. Will actively market the group's technical capabilities to clients and the scientific community. Develop additional expertise, gain additional industry exposure, and establish new and expanded client base through unique technical consulting services. Attract and develop new projects and clients.

The candidate should have M.D. J.D. or M.S./Ph.D. degree in bioengineering, mechanical engineering, materials engineering, polymer science or a related engineering field. Must have 10+ years of professional experience with 5+ years as a consultant. Should have direct experience in a product development environment in medical devices is required, including working knowledge of medical device design control, Risk Management, MDR and FDA regulatory environments. Demonstrated experience in working with FDA and successful completion of 510(k) submissions and pre-IDE, IDE, PMA original submissions and subsequent revisions/supplements for medical devices required. Must be a recognized expert in own field with a strong publication history. Established client relationships and a thriving consulting business is highly desirable. Must be able to attract projects and continuously expand own business volume to support full-time staff and have the skills needed to manage, develop, and promote a group of highly motivated professionals. Testifying experience in trials and/or before government panels is an asset.
Legal 10 - 0 Full-time 2014-03-01
 
Health Care/Attorney/In House/Menlo Park, California
Refer job# PTTN44275
 
Senior Managing / Principal Engineer/Scientist - Regulatory, Biomedical Engineering The candidate will manage and execute complex projects related to preclinical strategy and all phases of the FDA product review and approval process of medical devices in support of clients. Will actively market the group's technical capabilities to clients and the scientific community. Develop additional expertise, gain additional industry exposure, and establish new and expanded client base through unique technical consulting services. Attract and develop new projects and clients.

The candidate should have M.D. J.D. or M.S./Ph.D. degree in bioengineering, mechanical engineering, materials engineering, polymer science or a related engineering field. Must have 10+ years of professional experience with 5+ years as a consultant. Should have direct experience in a product development environment in medical devices is required, including working knowledge of medical device design control, Risk Management, MDR and FDA regulatory environments. Demonstrated experience in working with FDA and successful completion of 510(k) submissions and pre-IDE, IDE, PMA original submissions and subsequent revisions/supplements for medical devices required. Must be a recognized expert in own field with a strong publication history. Established client relationships and a thriving consulting business is highly desirable. Must be able to attract projects and continuously expand own business volume to support full-time staff and have the skills needed to manage, develop, and promote a group of highly motivated professionals. Testifying experience in trials and/or before government panels is an asset.
 
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