Jaclyn Loushine

About Jaclyn Loushine

Define strategic regulatory requirements necessary for regulatory approval of drug delivery combination and digital health products. Lead regulatory strategy for projects and provide direction to project teams to support key new product development, clinical studies and post-market product modifications. • 19 year career in quality and regulatory in the pharmaceutical and medical device industries- Passion for developing and mentoring- Lead teams through successful health authority interactions including building key relationships and reputation both internally and externally• Develop global regulatory strategies and prepare submissions for new product introductions- Responsible for combination product content and health authority Q&A for Marketing Authorization Applications • Review advertising and promotional material for both drugs and devices- Develop and support new and innovative processes for bringing standalone/digital devices to market. • Support medical devices from product concept to market launch to obsolescence• Quality auditing and regulatory due diligence • Regulatory Affairs Certified (RAC)- former

Experience

1. Senior Director, Global Regulatory Affairs, Precision Medicine and Digital Health

   Takeda

   Nov 2025 — Present · US

Education

• University of Minnesota

  BS Chemistry, Chemistry

  2000 — 2004

Skills

• Iso 13485
• Medical Devices
• Capa
• Quality System
• V&V
• Cross-Functional Team Leadership
• Iso 14971
• Fda
• U.s. Food and Drug Administration (Fda)
• Design Control
• Quality Control
• Gmp
• Regulatory Affairs