Dawn Davisson Email & Phone Number

Gainesville, FL, US

• Senior Director Regulatory Affairs, April 2018-presentDirector Regulatory Affairs, June 2012 - April 2018Responsible for the Regulatory activities for the company, with oversight of premarket regulatory submissions for.
• Project lead and key contributor for multiple EU MDR transition workstreams and oversaw completion of Class I Technical Documentation to meet the 2021 MDR Date of Application.
• Partner with all global business units (Knee, Hip, Extremities, Spine, and Biologics), to enable operation within company and regulatory guidelines.
• Lead the team creating, compiling, and maintaining global technical documentation in support of new product development and registration.
• Key contributor on regulatory strategy for clinical evaluation reports and post market clinical follow-up.
• Responsible for all product labels, Instructions for Use, and UDI.

Gainesville, FL, US

• Senior Manager, Engineering and Development, Packaging Engineering, Feb 2012 - June 2012Packaging Engineering Manager, Sept 2006 - Feb 2012Senior Packaging Engineer, July 2004 - Sept 2006
• Organized and oversaw the work for up to 6 direct reports in design, development, qualification, and implementation of packaging for sterile and nonsterile orthopedic medical devices.
• Prepared and submitted continuous improvement proposals related to design concepts, attributes, and performance.
• Engaged in the development and validation of aging studies to extend product shelf life.
• Oversaw the migration of labeling data from FoxPro into enLabel and Prisym.
• Provided mentorship and professional guidance to junior members of the Engineering and Development team.

Staff Packaging Engineer, March 2002 - July 2004Senior Packaging Engineer, January 1998 - March 2002Responsible for design, development, and qualification of packaging for sterile medical devices.

Production planning for diagnostic catheters and accessories.

Bs, Industrial & Systems Engineering

Ms, Engineering Management