Hannah Smith

About Hannah Smith

I bring a proven track record of delivering regulatory and quality expertise across a…

Experience

1. Associate Director, Global Regulatory Strategy Devices Npd

   Bayer

   Aug 2019 — Present

   2020 Radiology DreamFund Grant recipient: Making Science Make Sense: STEM Outreach in Pittsburgh’s Communities • Develops and implements global Regulatory strategies for new product development projects, ensuring that key pre-market Regulatory requirements are captured in global regulatory strategies and development plans, while balancing business objectives. • Develops and implements regional/local Regulatory project goals for NPD projects. • Leads and participates on NPD Regulatory Affairs Teams and Global Project Teams. • Leads preparations and conduct/follow-up for meetings and teleconferences with US/Can/EU HA officials and aids in other country HA meeting preparation/conduct/follow-up. • Responsible for the preparation of 510(k) and international submissions as well as preparation and maintenance of EU technical files to ensure European Medical Device Regulations compliance. • Ensure submissions and technical documentation are consistent with the business strategy. Develop regional/local submission/technical documentation materials, guide the review process, technical consistency, compliance to local and global HA regulations and completeness of submission. • Clearly communicates recommended strategies and changing local regulatory requirements. • Ensures assigned NPD device compliance, including change management and ad/promo review, with all applicable regulations and standards and proactively monitors the competitive landscape and advises the organization on actions to be taken with regard to opportunities or threats. • Proactively identifies regulatory issues/risks and designs/executes mitigation plans. • Acts as a company liaison to industry trade associations. Review and suggest possible organization reaction to new or proposed legislation. • Provides Regulatory support and cross-functional activity for assigned device product recalls and risk management documentation. • Contributes to Regulatory Affairs functional improvement initiatives.

Education

• University of Pittsburgh

  Bioengineering, Minor - Chemistry

  2010 — 2014

• Point Park University

  Biotechnology Apprenticeship, Biotechnology

  2009

• Community College of Allegheny County

  EMT-B

  2013 — 2014

• North Hills High School

  High School Diploma

  2008 — 2010

Skills

• Written & Oral Presentation Skills
• Microsoft Word
• Laboratory Skills
• Programming
• Customer Service
• First Aid Training
• Teamwork
• Teaching
• Bioengineering
• Global Regulatory Compliance
• Emergency Services
• Emergency Medicine
• Solidworks
• Microsoft Office
• Biomedical Engineering
• Event Planning
• Volunteering
• Laboratory
• Leadership
• Cpr Instruction
• Team Leadership
• Microsoft Excel
• Public Speaking
• Community Service
• Powerpoint
• Research
• Quality Assurance
• Leadership Development
• Philanthropy
• Regulatory Affairs