Medical Writer Resume Lake Forest, IL - Hire IT People

SUMMARY:

Creative, self - driven, organized person seeking a challenging position dat will allow me to utilize my professional qualifications, scientific noledge, and technical skills for driving solutions in teh medical device field

TECHNICAL SKILLS:

Computer: Expert in MS Word, Outlook, and PowerPoint; Familiar wif MS Excel

Technical: Working noledge of SAP DMS/PS, SharePoint, and Regulatory DMS; Familiar wif 21 CFR 820 and CM

Language: Fluent in Hindi and English; Familiar wif Spanish

PROFESSIONAL EXPERIENCE:

Confidential, Lake Forest, IL

Medical Writer

Responsibilities:

Created submission documents in MS Word for Invitro Diagnostic Regulation (IVDR) product submissions
Prepared technical documents by using submission templates and medical writing format/style guidelines to support international regulatory submissions for diagnostic assays and instruments
Participated in team meetings to discuss prioritization of IVDR technical file (TF) chapters for immunoassays
Interacted wif cross-functional team members to communicate teh status and review of TF chapters
Electronically routed TF chapters in teh International Regulatory Information System (IRIS) application

Confidential,Lake Forest, IL

Project Assistant II

Responsibilities:

Supported Confidential Integration by extracting and maintaining New and Marketed Packaging Product document specifications into Excel for migration from SAP DMS into SAP Packaging Solution (PS)
Created and revised material specifications for manufacturing components related to primary/secondary packaging, testing, and shipping of Hospira/ Confidential products
Processed changes to product specifications and drawings by abiding to engineering change control processes to ensure revisions were made in compliance wif business expectations
Participated in weekly status meetings and worked on multiple projects while adhering to required timelines

Product Development

Confidential

Responsibilities:

Collaborated wif a team to develop an obstetric drape to accurately measure blood loss after childbirth
Applied FDA quality system (QS) standards and design control to assure device safety and efficacy
Established teh Product Requirement Definition (PRD) to clearly articulate teh product’s features and behavior
Developed status reports and cost estimates to construct affordable prototype
Applied FDA quality assurance (QA) standards to an external cerebrospinal fluid (CSF) drainage system
Performed FMEA on CSF bag components and prepared a CAPA report for teh product complaint
Submitted a 510(k) on teh CSF bag including tests and measurements for teh product change