Mike Kliewer, Phd.

FAQ About Mike Kliewer, Phd.

• What is Mike Kliewer, Phd.'s address?

  Mike Kliewer, Phd. is located at
  Edmond, Edmond, United States

• What is Mike Kliewer, Phd.'s job title?

  Mike Kliewer, Phd. is a
  Oversees global regulatory operations including but not limited to leading the globalization of regulatory processes including document management systems and processes, expanding and maintaining the electronic document and submission systems, and coordinating the global budget and goal setting process. Integrates all regional as well as Pharmaceutical, Surgical and Vision Care activities to provide coordination and visibility to the businesses and the corporation. Plays a key role in ensuring that regulatory processes, procedures and systems are standardized and globalized. Regulatory lead in Bausch + Lomb Surgical Business Development with focus on evaluating Regulatory risks, global Regulatory path, and Regulatory personnel of possible targets for potential strategic alliance or acquisition.Provide lead support and efforts to investigate, analyze, plan, design, develop and implement Regulatory strategies for new and existing medical devices. Manage projects and lead cross-functional teams through all aspects of project life cycles. • Lead in Regulatory for “carve-out” of the Refractive franchise to merge the division with International company. This exercise included strategy to move manufacturing site, submit necessary US and International Regulatory filings, and transfer of registrations in Asia, Americas, and EEA. Coordinated activities to reach goal. • Provide Regulatory input to product development teams, defining the product requirements and test systems necessary to demonstrate product functionality. Support Global Regulatory filings in Asia, Amercias and EEA. • Active member of Patent Review Committee, Surgical Publication Approval Process Committee, and perform Regulatory due diligence for new products in Surgical.• Directed the development of flash lamp-pumped, diode-pumped and fiber lasers operating in either continuous or Q-switched mode for laser engraving and marking. Collaberated with marketing team to develop design specifications and engineering requirements. Performed management responsibilities over engineering and production final test. Responsible for coordinating with key global customers to develop systems to their specifications. • Led project team to develop company’s first generation fiber laser marker, which is currently the leading source of revenue for the company.Independent Consultant to several firms, providing strategies, product development expertise, SBIR proposals, and expert opinions in Regulatory Affairs and laser technology. Clients included Bausch & Lomb (present employer) and other companies in Japan, Australia and the Americas. • Generated SBIR proposals for non-invasive detection of blood glucose though the eye. • Technical advisor for firm to develop early-childhood Vision Screening device. • Contracted as acting R&D Manager and identifed, managed, and resolved technical issues for the 213 nm frequency quintupled Nd:Yag laser medical product. Developed specifications, budgets, and plans for future product and managed individuals in engineering, quality, and manufacturing. Partnered with CEO in fund raising efforts with Venture Capitalists. • Provided expert opinion on patent infringement for laser refractive company • Expert witness in Patent Infringement litigation on laser marking technology. • Director, Research and Development, Refractive Products for the laser refractive product (LSX). Managed the development of all aspects of the electro-optic laser product to insure continuity between products produced both domestically and internationally. Manager of “LASIK Project” for the flagship laser refractive product from concept to finished product, overseeing individuals in engineering, field service, sales, marketing, clinical training, materials, manufacturing, regulatory, quality, and accounting. Project Management responsibilities included planning development, schedule, and budget from project inception to product launch. Bausch & Lomb

• What industry does Mike Kliewer, Phd. currently work in?

  Mike Kliewer, Phd. currently works in the
  Bausch & Lomb

• What is Mike Kliewer, Phd.'s area of expertise?

  Mike Kliewer, Phd. specializes in
  Oversees global regulatory operations including but not limited to leading the globalization of regulatory processes including document management systems and processes, expanding and maintaining the electronic document and submission systems, and coordinating the global budget and goal setting process. Integrates all regional as well as Pharmaceutical, Surgical and Vision Care activities to provide coordination and visibility to the businesses and the corporation. Plays a key role in ensuring that regulatory processes, procedures and systems are standardized and globalized. Regulatory lead in Bausch + Lomb Surgical Business Development with focus on evaluating Regulatory risks, global Regulatory path, and Regulatory personnel of possible targets for potential strategic alliance or acquisition.Provide lead support and efforts to investigate, analyze, plan, design, develop and implement Regulatory strategies for new and existing medical devices. Manage projects and lead cross-functional teams through all aspects of project life cycles. • Lead in Regulatory for “carve-out” of the Refractive franchise to merge the division with International company. This exercise included strategy to move manufacturing site, submit necessary US and International Regulatory filings, and transfer of registrations in Asia, Americas, and EEA. Coordinated activities to reach goal. • Provide Regulatory input to product development teams, defining the product requirements and test systems necessary to demonstrate product functionality. Support Global Regulatory filings in Asia, Amercias and EEA. • Active member of Patent Review Committee, Surgical Publication Approval Process Committee, and perform Regulatory due diligence for new products in Surgical.• Directed the development of flash lamp-pumped, diode-pumped and fiber lasers operating in either continuous or Q-switched mode for laser engraving and marking. Collaberated with marketing team to develop design specifications and engineering requirements. Performed management responsibilities over engineering and production final test. Responsible for coordinating with key global customers to develop systems to their specifications. • Led project team to develop company’s first generation fiber laser marker, which is currently the leading source of revenue for the company.Independent Consultant to several firms, providing strategies, product development expertise, SBIR proposals, and expert opinions in Regulatory Affairs and laser technology. Clients included Bausch & Lomb (present employer) and other companies in Japan, Australia and the Americas. • Generated SBIR proposals for non-invasive detection of blood glucose though the eye. • Technical advisor for firm to develop early-childhood Vision Screening device. • Contracted as acting R&D Manager and identifed, managed, and resolved technical issues for the 213 nm frequency quintupled Nd:Yag laser medical product. Developed specifications, budgets, and plans for future product and managed individuals in engineering, quality, and manufacturing. Partnered with CEO in fund raising efforts with Venture Capitalists. • Provided expert opinion on patent infringement for laser refractive company • Expert witness in Patent Infringement litigation on laser marking technology. • Director, Research and Development, Refractive Products for the laser refractive product (LSX). Managed the development of all aspects of the electro-optic laser product to insure continuity between products produced both domestically and internationally. Manager of “LASIK Project” for the flagship laser refractive product from concept to finished product, overseeing individuals in engineering, field service, sales, marketing, clinical training, materials, manufacturing, regulatory, quality, and accounting. Project Management responsibilities included planning development, schedule, and budget from project inception to product launch.

• Which languages does Mike Kliewer, Phd. speak? 

  Mike Kliewer, Phd. speaks the following languages:
  No languages available.

• Which industries has Mike Kliewer, Phd. previously worked in?   

  Mike Kliewer, Phd. has prior experience in the following industries:
  Bausch & Lomb , Bausch & Lomb , Baubly’s Control Laser , Control Laser Corporation/Control Systemation Inc , Michael & Associates , LaserSight Technologies

• What is Mike Kliewer, Phd.’s work experience?  

  Mike Kliewer, Phd. has the following professional experience:
  Bausch & Lomb , Bausch & Lomb , Baubly’s Control Laser , Control Laser Corporation/Control Systemation Inc , Michael & Associates , LaserSight Technologies .

• How can I find Mike Kliewer, Phd. on LinkedIn?  

  You can view Mike Kliewer, Phd.’s
  LinkedIn profile at LinkedIn URL.

• What are Mike Kliewer, Phd.’s work email addresses?  

  Mike Kliewer, Phd.’s work email addresses are
  [email protected].

• What company does Mike Kliewer, Phd. work for?  

  Mike Kliewer, Phd. works at
  Bausch & Lomb