Robin Wasserman, Phd Email & Phone Number

Mountain View, Ca, Us

Abbott Park, Illinois, Us

Minneapolis, Mn, Us

• Lead a diverse team to transform regulatory submission and product release activities, enabling faster iteration of high quality, safe and effective products to customers.• Provide vision and direction to create interactive dashboards and data analytics for strategic decision-making• Develop talent within the team and create a talent pipeline to ensure we provide the best possible customer and employee outcomes

Minneapolis, Mn, Us

• Lead a diverse team to identify, develop, implement and extend solutions that automate agency submission and product release activities, QMS management, and other enterprise activities based on stakeholder needs and desires; with a laser focus on “delighting the customer” • Provide vision and direction for the creation of real-time interactive PowerBI-based dashboards for strategic decision-making • Manage development of apps on a cloud-based platform (Mendix) to streamline regulatory submission and product release processes

Minneapolis, Mn, Us

Developed and streamlined processes required for obtaining and maintaining worldwide approvals, for all Medtronic product lines. Collaborates cross-departmentally to improve workflows related to regulatory submissions and product release. Drives process improvements for preparing, updating, maintaining, and storing technical documentation. SharePoint power user. Advanced skills in Microsoft Word, Excel, and PowerPoint. Acting Regulatory Operations Manager, helping coordinate efforts related to regulatory assessment of new products and changes (RAN/RAC), product release shipment authorization (PSRA), GTS licensing, GTIN data gathering, UDI (GUDID submission), and EU MDR transition, including EUMDR technical documentation and EUDAMED submissions.

Minneapolis, Mn, Us

Responsible for, and supports, an array of medical/technical documentation activities associated with the Regulatory Affairs organization. Collaborates with other medical/technical writers, regulatory affairs specialists, and engineers to prepare, edit, and organize a variety of technical documents. Guides the proper drafting of regulatory submissions, for obtaining and maintaining worldwide approvals, for all Medtronic product lines.Increases efficiency and accuracy of Regulatory Affairs documentation processes through the development of new procedures using the Agile PLM System. Develops, creates, and validates automated workflows through SharePoint Online for Regulatory Affairs. Supports/teaches SharePoint design, InfoPath and workflow activities to help streamline processes across departments, including Quality and Marketing.Assists in external audit activities.Co-Founder of Medtronic Jewish Community, an employee resource group dedicated to providing an environment for Jewish cultural expression, education and awareness; and promoting excellence and inclusiveness in a diverse workplace. It serves as a resource for the professional development and engagement for its members. MJC is open to all employees regardless of any religious affiliation, lack of affiliation or cultural background.

Chicago, Il, Us

Provided tutoring in the fields of biology, biochemistry, chemistry, and algebra to a wide variety of clients, from middle school students struggling at the basic level to community college students having difficulty with advanced courses.

Helped students develop critical-thinking abilities by gaining an understanding of mathematical concepts at the high school level. For the 2015-2016 school year, taught Algebra 1B, Algebra 1, and Algebra 2 Honors.

Design websites, market original art, maintain productive psychological and artist office including, billing, receiving, insurance, and patient schedules.

Identifies and summarizes key issues related to worker’s compensation insurance claims in the area of Neurology.

Assisted attorneys in drafting and prosecuting patent applications, and conducted legal research, primarily in the biotechnological area.

Us

Designed and cloned both adenoviral and retroviral vectors expressing the human p53 gene for use in gene therapy protocols targeting lung cancer patients. Preliminary results indicated that several of these vectors have increased stability when transfected into producer cell lines. Successfully developed and used a yeast 2-step gene replacement YAC (yeast artificial chromosome) system to isolate various adenovirus derivatives. Began preliminary experiments on a novel adenoviral based expression system designed to increase transgene expression and decrease immune response of the resulting therapeutic virus. Provided clinical support to a head and neck cancer Phase I trial by successfully screening patient serum samples for viral dissemination using a PCR-based assay.

Cambridge, Massachusetts, Us

Interaction Among DNA, DNA Topoisomerase II, and Anticancer DrugsAdvanced understanding of ternary complexes consisting of DNA, DNA Topoisomerase II and anticancer drugs that target DNA Topoisomerase II; specifically identified mechanisms of resistance to such drugs. Developed and used a yeast system to identify top2 mutants expressing enzymatically active, drug-resistant DNA Topoisomerase II. Overexpressed, purified and characterized several of these mutant enzymes.The results of these studies indicated that mechanisms leading to cellular resistance can include reduction of the nuclear concentration and attenuation of the intrinsic catalytic steps of the enzyme. Results have significant implications for clinical strategies aimed at circumventing the phenomenon of multidrug resistance. In addition, cloned the human TOP2 gene into a yeast expression vector. Demonstrated that the recombinant human DNA Topoisomerase II* is functionally active in yeast. Overexpressed and purified this recombinant human enzyme from yeast and showed it to be drug sensitive in vitro demonstrating that yeast strains expressing human DNA Topoisomerase II* provide a convenient system for studying drugs targeting this important system.

Cambridge, Massachusetts, Us

Designed a laboratory experiment to demonstrate the effects of restriction enzymes and DNA Topoisomerases on DNA. Wrote the introduction, experimental protocol and recitation questions for the accompanying laboratory manual. This experiment was implemented by the 'introduction to Molecular Biology" course (Biochemistry 10) for Harvard undergraduate students.

Cambridge, Massachusetts, Us

Individually taught a section of the "Introduction to Biochemistry" course (Biochemistry 10A) for Harvard undergraduate students.

Cambridge, Massachusetts, Us

Individually taught a section of the "Introduction to Molecular Biology" course (Biochemistry 10) for Harvard undergraduate students.

Conducted research on the role of nucleosome positioning in gene regulation. Reconstituted histone core particles on two different DNA sequences to compare the binding affinity of a putative nucleosome positioning sequence to bulk nucleosomal DNA. The nucleosome positioning sequence from the 5S gene of Lystechinum variegates (sea urchin) was found to have an approximately 2-fold higher affinity.

Studied mitochondrial DNA replication. Utilized a DNA binding assay in an attempt to isolate a possible DNA binding factor involved in mitochondrial DNA replication. Initiated studies on a method to recover a primase involved in mitochondrial DNA replication.

Tested and analyzed a spectrophotometric assay designed to replace the Draize (rabbit eye irritation) test as a method for determining the potential human health hazards of commercial products.Selected Patents Written and/or Prosecuted

Ph.D, Biochemistry And Molecular Biology

B.S, Biochemistry

High School Diploma

Education record