Ghaleb Anwar

Irvine, CA *****

E-mail: adc9rc@r.postjobfree.com

Phone: 949-***-****

Summary

- Experienced Specialist in medical device product labeling process and documentation management

- Demonstrated history in working in an FDA regulated Medical Device companies with good working experience in FDA, ISO and EU MDR labeling requirements

- Experienced in SAP, Agile and Teamcenter PLM

- Experienced in IPM labeling platform (En-Label software)

- Six Sigma White Belt (CSS certified), Internal Audit certified (Jordan Academy for Quality Management)

Work experience

Labeling Specialist Oct 2019 – Present

Philips Respironics (contractor)

Carlsbad, CA

• Review, proofread and redline label content to ensure clarity, correctness and compliance with company procedures, regulatory bodies and standards

• Support the EU MDR label requirements project by identifying labels and updating them accordingly

• Create and submit ECO worksheet and other accompanying documents

• Schedule and manage peer reviews with reviewers to sign off approval

• Process and approve changes through SAP and collaborate with doc control for final release

• Create and update label verification protocol and label requirement specification

• Collaborate with cross functional teams; RA, QE, Purchasing, R&D to evaluate and finalize label changes

Labeling Design Specialist June 2019 – Oct 2019

Natus Medical, Inc. (remote contractor)

Seattle, WA (working remotely)

• Review, redline and proofread label content and symbols ensuring compliance with company’s SOPs, FDA, EU and ISO15223:2016 requirements

• Create Engineering Change Orders to release new or updated labels

• Create and execute Verification report and updating BOMs per engineering request and following governing procedures

• Review Design Inputs Labeling Requirements (DILR) and release in PLM system

• Collaborate with design engineers to support design change in labeling process Change Analyst / Labeling Specialist Nov 2018 – June 2019 Johnson and Johnson Surgical Vision (contractor)

Santa Ana, CA

• Support the quality department in the JJSV rebranding project

• Support the EU MDR requirements in updating the company’s SOPs

• Review, proofread and redline documents ensuring compliance with company’s procedures and regulatory bodies

• Update product labels to reflect the EU MDR

• Track and update project in Microsoft Project and Microsoft Teams

• Participate with labeling manager and RA rep to identify labeling gaps and the actions required to close those gaps to comply with EU MDR requirements

• Collaborate with cross-functional teams and document owners in the timely release of documents via the change order process and to solve any issues or discrepancies in change orders

QA / Labeling Specialist Nov 2017 – Nov 2018

Vyaire Medical, Inc. (contractor)

Yorba Linda, CA

• Proofread all label content for accuracy and compliance with company’s SOPs, quality, regulatory, ISO and FDA requirements

• Execute strategies to develop new domestic and global content in support of new product launches

• Analyze, verify and upload labeling content, symbols, trademark statements to En Label

• Update and upload released documents in the company’s share point site

• Collaborate with engineering and regulatory, as applicable, to complete Product labeling projects

Labeling / Documentation Specialist April 2017 – Oct 2017 Edwards Lifesciences (contractor)

Irvine, CA

• Work independently on sections of projects and/or lines of production in the Global Labeling Department as per the FDA and ISO requirements

• Create ECRs through PLM system to implement International label items into product configurations

• Analyze, evaluate redlined text and graphics for labeling

• Follow and maintain timetables for creating new/revised content and labeling in a cost-effective manner

• Work closely with graphic designers, CGL specialists to address issues related to label production and on the line projects

Proofreader April 2016 – Oct 2016

CareFusion (contractor)

Yorba Linda, CA

• Proofreading all label copy content and instructions for use labeling;

• Interpret, analyze and compare existing content in a labeling content system

• Collaboration with labeling stakeholders to support the design of labels and IFUs

• Manage multiple documentation assignments in various stages of production to ensure critical deadlines are met

• Process, track and maintain written documents in electronic and manual controlled documentation systems per company’s procedures

• Work closely and coordinating with graphic designers and SMEs

• Follow and maintain timetables for creating new and revised label content Regulatory Affairs Associate April 2014 – Oct 2015 ICCB Group (full time)

Amman – Jordan

• Support RA management in the development and implementation of RA process

• Maintain regulatory database and documentation and produce records and reports as needed

• Obtain and distribute updated information regarding domestic or international requirements and regulations

• Coordinate efforts associated with the preparation of regulatory documents or submissions to the Regulatory Agency in Jordan

• Communicate with the regulatory agency regarding pre-submission procedures, compliance requirements, and follow-up of submissions under review

Education

• BA Political and Management Science

Professional skills

• Bi-lingual Arabic – English

• Agile and Teamcenter Ignite PLM, SAP and enLabel software

• Highly organized, detail and quality oriented

• A go-getter, proactively engage in any project development with the ability to produce results

• Strong organizational skills and time management skills

• Experienced in project management; Microsoft Project, Teams and SharePoint

• Ability to function well under pressure and balance requirements

• Excellent written and verbal communication skills

• Team player with excellent interpersonal relationship

• Multi-tasking with ability to prioritize

linkedIn profile: https://www.linkedin.com/in/ghaleb-alwiswasee-5b5332a/

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