Senior Regulatory Affairs Specialist

• Dec 2019 - Present

Regulatory Affairs Specialist

• Nov 2017 - Dec 2019

Regulatory Affairs Specialist

• Jun 2016 - Nov 2017

Develop and maintain market authorization across infusion products including disposables and software. Demonstrate critical thinking in reviewing and approving product changes. Perform administrative regulatory tasks such as; Canada Licensing, Certificates to Foreign Government, Product hold/release, notarizations, Technical File and Declarations of Conformity updates, Letter to File drafting, Marketing Material review and approval and 510(k) preparation and submission . Develop and maintain market authorization across infusion products including disposables and software. Demonstrate critical thinking in reviewing and approving product changes. Perform administrative regulatory tasks such as; Canada Licensing, Certificates to Foreign Government, Product hold/release, notarizations, Technical File and Declarations of Conformity updates, Letter to File drafting, Marketing Material review and approval and 510(k) preparation and submission .

QA Documentation Coordinator

• Jun 2015 - Jun 2016

Adhere daily to strict documentation requirements per ISO 13485 and 21 CFR 820. Maintain updates to quality system studies, design history reports and records, and essential job aids created within the company. Execute and manage projects as assigned with excellent deadline retention. Deviations to quality system documents are examined carefully with meticulous attention to detail. Ensure that recorded information meets specifications to follow cGMP steps and limits. Adhere daily to strict documentation requirements per ISO 13485 and 21 CFR 820. Maintain updates to quality system studies, design history reports and records, and essential job aids created within the company. Execute and manage projects as assigned with excellent deadline retention. Deviations to quality system documents are examined carefully with meticulous attention to detail. Ensure that recorded information meets specifications to follow cGMP steps and limits.

Quality Assurance Specialist

• Feb 2014 - Jun 2015

Manage quality control process for Next Generation Sequencing products in a Genomics analysis facility. Maintain multiple projects at one time and work with cross functional teams in developing the best sequencing product for clients within and outside the University of Minnesota. Assist Sanger Sequencing manager in troubleshooting sequencing product for optimal results.

Junior Scientist

• Jan 2013 - Feb 2014

Conduct research using several bacterial strains and performing quantitative microbiological techniques. Worked in the Laboratory Medicine and Pathology department at the U of M under assistant and associate scientists, performed general laboratory maintenance and basic ordering and organizing of laboratory supplies and equipment.