Elizabeth A. Galella Email & Phone Number

Eatontown, New Jersey, Us

UDI COMPLIANCE • Successfully led a multi-disciplinary team to ensure company’s compliance with FDA class II medical device Unique Device Identification (UDI) regulations by Sept 24, 2016. • Responsible for UDI-compliant labeling for the company’s products and private-label products• Over 800,000 UDI-compliant kits & cases have been shipped since 9-24-16 without customer complaint • Established and maintain the GUDID database (FDA)• Wrote and implemented SOPs for UDI and GUDID QUALITY SYSTEM (ISO:13485) • Provide regulatory guidance as company transitions to ISO 13485:2016 & MDSAP Part of the audit team representing the company's interests to FDA and certification organizationsMEDICAL DEVICE SUBMISSIONS• As part of a team, submitted 510(k) applications and pre-submissions to FDA • Wrote, edited and compiled documents for regulatory submissions• Multiple medical device licenses/amendments successfully submitted to CMDCAS• Submitted technical files to EU authorized representative to obtain CE marking on products• Responded to queries from regulatory authorities (both verbal and written)REGULATORY GUIDANCE• Provide regulatory guidance during design and development of new products

Eatontown, New Jersey, Us

REGULATORY SKILLS:• Lead company's successful participation in ISO:13485 Voluntary Audit Report Submission Pilot Program (FDA) for 2 years. • Prepared electronic submissions following FDA guidelines• As part of a team, assisted in writing and editing of 510(k) submission • Successfully submitted medical device license applications & amendments to CMDCAS• Reviewed and edited IFUs and other labeling to assure compliance with regulations• Performed Risk Analysis for company's devices with the goal to mitigate risk• Responded to queries from regulatory agencies (both verbal and written)• Provide regulatory guidance during design and development of new productsQUALITY ASSURANCE SKILLS:• Update and maintain company's Device Master Records and Design History Files• Participate in ISO:13485 audits and vendor audits• Communicated the company's response to audits, CAPA and Root Cause Analysis• Review and update company SOPs

Lincroft, New Jersey, Us

Taught Biology to non-science majors.

Taught Biology, Biology Honors, Environmental Science, Forensic Science, Science Enrichment

Taught natural science classes to 3rd to 5th grade students.

To discover genes that interact with the p53 tumor suppressor, the following research project was done:• A rat embryo fibroblast cell line containing a temperature-sensitive p53 tumor suppressor gene was grown at both the permissive and non-permissive temperature. • Comparison of RNA obtained from cells grown at the 2 temperatures resulted in 17 genes with differential expression isolated from 15,000 analyzed genes. • Genes were cloned and sequenced. The DNA sequence and deduced protein sequence was analyzed by GCG sequence analysis software. Ten genes were identified as novel.• Work was published in the scientific journal Oncogene 15:1079-1085.

Boonton, New Jersey, Us

Assisted in planning, experimental design and execution of research projects. Presented scientific results at department and company meetings.Contributed to the writing and editing of articles for scientific journals. Presented abstracts at national scientific meetings.Initiated and maintained company library.

Master Of Science (Ms), Biology, General

Bachelor Of Science (Bs), Biology, General

Clinical Development And Regulatory Affairs