Ashley Dynan

About Ashley Dynan

A dynamic and diligent solutions-oriented regulatory and quality management professional recognized for creative problem solving and consistent performance excellence. With 18+ years of pharmaceutical and medical device Quality Management and Regulatory Affairs experience including strategies ensuring compliance with global regulations and successfully bringing innovative products to market. Adept at building high-performing quality focused teams, navigating the complex regulatory environments and fostering strong relationships with regulatory agencies.

Experience

1. Senior Director of Regulatory Affairs

   Apiject Systems

   Apr 2023 — Present · US

   My responsibilities include:Developing and influenceing guidance and requirements for organization\'s regulatory strategies.• Interpret Regulatory Authority policies and guidance and correctly apply them as appropriate in productdevelopment and labeling regulatory activities including EUMDR for ApiJect devices.• Advise on and direct device/combination product regulatory compliance initiatives.• Lead, support, and coach direct reports. Set performance expectations and priorities to enable goal achievement• Provide mentorship to regulatory staff• Represents ApiJect at external events.• Supports combination device regulatory affairs discipline throughout the product lifecycle, including Design, Development, Promotion and Advertising, Labeling, Change Control,Commercialization, and Operations.• Utilize knowledge of domestic and international laws, regulations, and guidance that affect assigned devices in varies regulatory markets.• Influence and partner with cross-functional teams in ApiJect organization and assess project risks, develop plans and strategies for regulatory risk mitigation.

Education

• Concordia University Irvine

  Bachelor's degree, Biological and Biomedical Sciences

  2004 — 2006

• Salve Regina University

  N/A, Pre-Medicine/Pre-Medical Studies

  2002 — 2004

• Benedictine University

  Master of Public Health (M.P.H.), Health/Health Care Administration/Management

  2007 — 2011

Skills

• Team-Oriented
• Team Leadership
• Organizational Development
• Process Improvement
• Medical Devices
• Capa
• Quality System
• V&V
• Organizational Effectiveness
• Standard Operating Procedure (Sop)
• Fda Gmp
• Compliance
• Lims
• Regulatory Affairs
• Biotechnology
• Laboratory
• Collaborative Work
• Iso 13485
• Internal Audit
• Gmp
• U.s. Food and Drug Administration (Fda)
• Quality Assurance
• Time Management
• Multi Tasking
• Close Attention to Detail
• Design Control
• Glp
• Gxp
• Trackwise