Manufacturing, Global Regulatory Affairs, Labeling, Marketing, Failure Analysis Expert Consultant Resume
Resume of ZFF

  • Manufacturing
  • Research and Development
  • Global Regulatory Affairs
  • Failure Analysis
  • Marketing
  • Medical Device Labeling

Master of Science, Public Policy & Business Management, Rochester Institute of Technology

Continuing Education, Biological Sciences, The Ohio State University

Bachelor of Arts, Speech and Hearing Sciences, Indiana University

Self directed and motivated Global Regulatory Affairs/Business professional with 15 years of progressive experience with regulated products, including medical devices (all classes), over the counter drugs, nutritionals and cosmetics. Experience managing personnel. Familiarity and success with product development and lifecycle management activities, strategy development, crisis management and due diligence activities. Experience communicating directly (verbal and written) with world-wide regulatory agencies to gain product approvals and resolve compliance issues. Served as witness for product liability lawsuits. Enjoys working in a dynamic and high energy environment.

Consultant, Kevin Kennedy Associates, Inc.

Providing expert global regulatory operations, research and development and business analysis consulting services to a wide variety of clients.

Director, Global Regulatory Affairs, a major global corporation

Leading all regulatory operations, intelligence and compliance systems for the corporation. Responsible for external audit activities, recalls and resolution of compliance issues world-wide. Evaluating and redesigning processes for change management and label/labeling development with partners from operations and marketing. Oversight of regulatory changes for maintenance of business projects. Lead negotiations with various government agencies including, but not limited too, US FDA, Health Canada, EU notified bodies, SFDA, ANVISA, and PMDA. Manage a team of 7 junior colleagues.

Program Manager, Research & Development, Bausch & Lomb Incorporated

Led a cross-functional (R&D, Marketing, Engineering) team with responsibility for the research and development of a new product line within a newly established portfolio. Responsible for the project budget, scope, quality, resources and timeline. Directed design control activities and maintained appropriate regulatory compliance status. Responsible for analyzing business and technical risks and formally communicating status to all levels of senior management.

Manager, Global Regulatory Affairs, Bausch & Lomb Incorporated

  • Developed global regulatory strategies for new products to facilitate faster agency approvals and subsequent market introductions. Aligned regulatory strategies with the overall business objectives as a functional leader on new product development teams.
  • Prepared submissions for global markets including, but not limited to, 510(k), PMA, IDE, CE Technical Files, Canadian DIN, to support new product and clinical study registrations for medical devices and over the counter drugs. Experience interacting directly with world-wide government agencies, including but not limited to, US FDA, Health Canada, SFDA (China), MHLW (Japan), EC and notified bodies.
  • Led failure investigations, provided regulatory guidance, and organized world-wide recalls. Managed external communication to accurately update government agencies and the public on the status of a Class 1 recall with considerable media attention.
  • Completed and obtained approval for 56 global registrations in one year to support the launch of a new Class II medical device that became the number one selling product for the company.
  • Managed 5 direct reports. Directed regulatory specialists project work activities. Provided guidance on career development and served as a professional mentor by engaging junior colleagues in the product development process and challenging existing operating procedures and performance metrics.
  • Reviewed, evaluated and approved technical reports for regulatory submissions, advertising and claims support. Provided guidance to marketing for the development of technical advertisements and labeling.
  • Reviewed and communicated to global stakeholders the impact of pending regulations and policy initiatives on business goals. Worked with colleagues to develop impact analysis and position statements on regulatory issues relevant to the eye care industry.
  • Participated during audits by regulatory agencies and developed written responses for corrective and preventative actions.
  • Developed a global labeling SOP for medical devices that streamlined the review process and provided visibility to all functional groups in order to meet global compliance commitments. Developed SOPs for Canadian Device Licensing and associated activities.
  • Presented to senior management and project teams utilizing PowerPoint and similar media to update current regulatory strategies, product development status, and policy changes.
  • Taught course on Crisis Management to FDA and industry representatives through Advamed (trade organization).

Associate Manager, Global Regulatory Affairs, Bausch & Lomb Incorporated

  • Prepared global product submissions for new products.
  • Participated on product development teams to provide regulatory input for development of regulatory strategies.
  • Assisted in the review of product labeling for lens care products.
  • Maintained records of product approvals and licensing activities for vision care products worldwide.
  • Assisted in the review of divisional policies and procedures.

Regulatory Affairs Manager, Gryphon Development/Bath & Body Works

  • General regulatory responsibility for all toiletries and over the counter drug products. Researched global regulatory requirements and government application process for various product categories including foods, non-monograph drug products, and dietary supplements.
  • Audited and worked with product manufacturers to assure compliance with Good Manufacturing Practices and other applicable regulations. Participated during inspections of facilities of potential new contract manufacturers for regulated products.
  • Served as company liaison with various governmental agencies including, but not limited to FDA, CPSC, EPA, Health Canada, and SCCNFP.
  • Member of new product development teams to assure compliance with regulations and advise on claims acceptability. Reviewed and approved formulations and related technical documents against relevant US and EU regulations.
  • Represented company on regulatory committees with trade associations and advised on pending legislation. Tracked and communicated pending US and EU legislation to management.
  • Member of a cross functional task force to design and implement an electronic formula control system to track the development of new products in an end to end process. Represented Regulatory Affairs for all product divisions and to assure the system included appropriate functional modules.

Quality Assurance/Research & Development, Gryphon Development/Bath & Body Works

  • Evaluated personal care and home fragrance product standards against specifications and worked with product development teams to develop new specifications.
  • Performed statistical samplings of shipped products, and analytical tests (pH, viscosity, specific gravity) on finished goods.
  • Participated on a cross-functional company team to develop and implement a positive release system for qualified vendors.
  • Developed and maintained a database to track the performance of over 200 vendors.
  • Wrote and revised standard operating procedures for Quality Assurance/Research and Development.

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