BS, Mechanical Engineering @
University of Missouri-Rolla
Technical Professional with 29 years of experience in developing a strong team approach in accomplishing organizational goals. Strengths include improving interdepartmental cooperation and communication, operational efficiency through optimization of resources and completion of projects on time and within budget. Instrumental in the development of new products that expanded divisional market. Regarded as a self-motivated, creative problem solver
Technical Professional with 29 years of experience in developing a strong team approach in accomplishing organizational goals. Strengths include improving interdepartmental cooperation and communication, operational efficiency through optimization of resources and completion of projects on time and within budget. Instrumental in the development of new products that expanded divisional market. Regarded as a self-motivated, creative problem solver and team player.
Corporate Regulatory Affairs @ From July 2012 to Present (3 years 6 months) Director, Regulatory Affairs @ Responsible for securing and maintaining regulatory clearance / licensure for company products in target markets, for providing strategic direction, oversight and alignment with company processes for all Regulatory Affairs functions. Ensuring company-wide compliance with all applicable U.S. and international regulatory requirements. Provide support for product development projects and commercialized product programs, and collaborate with key suppliers to ensure components and finished products manufactured for the company meet regulatory requirements. From November 2011 to May 2012 (7 months) Director, Regulatory Affairs @ Direct the Global Regulatory Department for the Respiratory & Monitoring Solutions Division regarding goals, objectives, leadership strategies, and employee development. From July 2007 to April 2011 (3 years 10 months) Manager, Corporate Quality/Regulatory Affairs @ Responsible for developing and implementing regulatory strategies in the Imaging Device area that are consistent with Mallinckrodt’s overall regulatory goals. Responsible for monitoring the safety, quality and efficiency of Imaging products marketed and sold by Mallinckrodt. From September 2001 to July 2007 (5 years 11 months) Manager, R&D Design Assurance @ Responsible for design reliability and control, regulatory registrations, labeling and design documentation. Manage/ Supervise CAD & Global Documentation and Design Assurance Group. From December 1995 to September 2001 (5 years 10 months) Senior Product Development Engineer @ Responsible for the development/ coordination of projects for new products and processes from conception through product introduction and problem solving/ liaison during manufacture/ market introduction. From August 1991 to December 1995 (4 years 5 months) Senior Product Development Engineer @ Responsible for the development and coordination of new products and processes for the medical industry. Supervised and coordinated activities of technicians; handle development from conception through first article inspection and problem solving/liaison during manufacture. Report on product feasibility and market potential. Participate in regulatory reporting. From April 1987 to August 1991 (4 years 5 months) Sr. Engineer @ Direct/coordinate Plastic Products Group activities in support of production and acceptance of nuclear weapons components. Performed liaison function between design and production to achieve technical, cost and schedule objectives. Duties included design improvement, planning budget and personnel strategies, reporting/communications and team supervision. From July 1986 to April 1987 (10 months) Product/Process Engineer @ Project/product/process engineering duties for Plastic Products Group. Design/improvement, testing/inspection and communications. From July 1982 to July 1986 (4 years 1 month) Associate Engineer @ Engineering support duties, Plastic Products Group. From January 1982 to July 1982 (7 months)
MBA, Management @ Rockhurst University From 1982 to 1985 BS, Mechanical Engineering @ University of Missouri-Rolla From 1977 to 1981 Scott Dickerhoff is skilled in: Regulatory Affairs, ISO 13485, Quality Assurance, Product Development, FDA, Quality System, Medical Devices, Design Control, R&D, Manufacturing, Software Documentation, Regulatory Requirements, Program Management, CAPA, Validation
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