Melissa Hooper has 10 years of experience managing and supporting regulatory and quality assurance projects. Her primary expertise is developing and maintaining quality management systems that ensure compliance to global and regional regulations. She is also practiced in supporting 510(k) regulatory submissions.

Melissa’s qualifications include the following:

Quality Assurance

  • Supported quality projects for both established and startup medical device companies.
  • Supported the creation and implementation of Quality Management Systems compliant with regulatory standards, including, but not limited to, ISO 13485, 21 CFR 820, MDD 9./42/EEC, and EU MDR 2017/745.
  • Prepared, performed, and participated in both internal and external audits.
  • Managed document control for ISO 13485 Quality Management Systems.

Regulatory Affairs

  • Supported 510(k) writing and submissions.
  • Supported the drafting and submissions of technical bulletins.

Melissa holds a B.S. in Earth and Space Sciences with an Emphasis in Biology from the University of Washington.