Customer Service Data Entry
Resume:
JULIE ZORKA-MACCLOSKEY
Plano TX 75075
*******@**.***
EDUCATION: HUNTINGDON COLLEGE
Montgomery, AL
Bachelor of Arts (BA) Major: Human Performance and Kinesiology Athletic Scholarship: 4 Years Women’s Soccer Team
EXPERIENCE: 17 years of PM experience. 11 years of Regulatory, Product Safety & Compliance, plus an additional 10+ years in healthcare focusing in the PT/OT/SLP industry. TECHNICAL SKILLS: Program Management, Project Management, Team Building, FDA, ISO13485 & ISO14971, Certified Lead Auditor, Individual Work, Cross Functional Team Leadership, Business Process Improvement, NC/CAPA, Health Hazard Evaluations, Product Field Action, Regulatory Filings, GMA, QMS, QMS Systems
(Salesforce, MasterControl, AGILE, Oracle) CRM systems (Trackwise, Salesforce, MasterControl, AGILE, Oracle), Site inspections, Coaching & Mentoring, Complaint Handling, Medical Device Reporting, EUMDR/MDD, HIPAA, Regulatory Documentation, Operations Management, CPT, Customer Support, MDSAP, Technical Documentation, Regulatory Findings, LTF, 510K, Strategic Planning, Microsoft Office Suite. GALLUP STRENGTHS: Achiever, Learner, Positivity, Developer, Individualization Domino’s Pizza
Plano, TX
Delivery Driver
(Oct 2024 – Current)
Making life a little simpler for others!
• Delivering quality food on time and safely to customers as a Food Delivery Driver at Domino's.
• Providing excellent customer service and communication skills while problem-solving on the go. FX Shoulder Solutions
Addison, TX
Regulatory Affairs Associate (Contract)
(Apr 2024 – Jun 2024)
Drafted and submitted regulatory registrations in US and EU ensure project deadlines are met
Worked with R&D to create and maintain DHF documents and Technical Documentation
Provided regulatory strategies for product development projects
Liaised with product development teams and assist with and/or prepare 510(k) submissions and Letters to File
Submitted notification of significant changes to competent authorities, notified bodies, and authorized representatives
Communicated with competent authorities, notified bodies, authorized representatives, and international distributors and provide documentation as needed
Ensured compliance with regulatory and registration requirements in all jurisdictions
Conducted annual audits and review contracts of authorized reps and international distributors
Provided regulatory support during third party audits of the company quality system and product documentation
Work with QA to update Post-Market Surveillance plans and reports annually and to submit PSURs and SSCPs as required
Maintained familiarity with company product lines, Class III, Class IIb, IIa, Class I implants and instruments ENOVIS
Lewisville, TX
Product Surveillance Specialist – Global Regulatory
(Oct 2020 – Feb 2024)
Support for all audits, internal and external, on Post Market responsibilities
Eliminated redundancy in all regulatory assessments of reportability, saving more than 3 hours daily work time to focus and all required regulatory responsibilities
Project Manager for HHEs and recall activities
Initiated 16 recalls
Responsible for monthly analysis of MDR, Recall, CAPA, Assessments and HHE data for entire business, communicating results to Senior Leadership
Assessed over 600 monthly, reported incident complaints to determine regulatory reportability
Generated and submitted over 150 monthly, initial and follow-up reports, to regulatory agencies as appropriate
Trained regulatory team member on assessments, MDR, Vigilance reporting
Interacted with regulatory agencies on adverse event reporting and recalls
Provided bi-weekly leadership, training, and mentorship for team members of all business units on the impacts of receiving complaints and communicating required information to gather
Streamlined HHE, Strategy and Recall Process SOPs
Streamlined complaints process and verbiage to eliminated 70% of complaints entered as “reported incidents”
Decreased late MDRs for surgical business unit
Eliminated need for 3rd party creation of MDRs and Vigilance reporting for surgical business unit
Completed required PSUR and PMRE submissions
Assisted with Global Product Registration
Assisted with 510(k) and Technical Files
INOGEN
Richardson, TX
Regulatory Affairs Specialist III (Senior)
Mar 2020– Jun 2020
Opened and owned a CAPA on the complaint process and all affected forms, work instructions and procedures
Author of company’s complaint procedure
Created a multi-pareto monthly reporting on post market complaints
Updated and streamlined the form utilized to report a Potentially Reportable Event
Updated and streamlined the Failure Investigation Form utilized by the Engineering Team
Educated employees on how to perform and document a reportable and non-reportable event
Educated Customer Care supervisors on the Regulatory Requirements of complaint intake
Updated two technical files
Updated two device master records
Researched and created documentation to sell two Bluetooth devices in Canada
Assisted Operations Manager on revitalizing and streamlining packaging and shipping procedures
Approved all Marketing Material (Blogs, SEOs, Ads, Promotions, New Product Presentations)
(Blogs, SEOs, Ads, Promotions, New Product Presentations) STRYKER
Flower Mound, TX
Sr. Regulatory Affairs Compliance Specialist
(Mar 2019 – Feb 2020)
Directed the preparation, hosting and scribing for all audits
ISO13485 Certified Internal Lead Auditor
Supported all internal and external audits including FDA and TUV audit
Supported and prepared all responsible managers for MDSAP audits
Defined and implemented post-market regulatory affairs and quality assurance systems and procedures
Developed, applied, and revised procedures to maintain and improve quality assurance standards
Project Manager for recalls, reviews and completes associated regulatory documentation
Responsible for all analysis of data and communicating results to Senior Leadership
Reviewed all customer complaint reports to determine regulatory impacts
Generated and submitted initial and follow-up reports to regulatory agencies as appropriate
Reviewed all regulatory team members’ initial and follow-up submissions to regulatory agencies
Interacted with regulatory agencies on adverse event and vigilance reporting
Compiled, reviewed, and analyzed data for trending purposes
Complaint Divisional Process Owner
Recommended corrective and/or preventive actions to address non-conformities and deviations.
Worked closely with New Product Development (R&D) teams to ensure required testing is completed in timely manner
Interacted with customers and sales force to solve reliability issues and/or complaints
Provided leadership, training, and mentorship for team members in all business functions
CAPA and Non-Conformance owner
STRYKER
Flower Mound, TX
Regulatory Affairs Compliance Specialist
(Jun 2013 – Feb 2019)
Interacted with customer and Sales Force to solve reliability issues and/or complaints
Assisted leadership team defining and implementing post-market regulatory affairs and quality assurance systems and procedures
Assisted leadership team developing, applying, and revising procedures to maintain and improve quality assurance standards
Project Manager for recalls, reviewed and completed associated regulatory documentation
Responsible for all analysis of data and communicating results to Regulatory and Quality Management
Reviewed all customer complaint reports to determine regulatory impacts
Generated and submitted initial and follow-up reports to regulatory agencies as appropriate Complaint Lead for Business Unit
Interacted with customers and sales force to solve reliability issues and/or complaints
Provided leadership, training, and mentorship for team members in all business functions
CAPA duties included opening the proper Non-Conformances found during audits, working with the owners of each NC to determine if a CAPA is necessary or if the NC will incorporate all the investigation and further requirements, and working with the CAPA team if the NC is escalated to a CAPA KENT RATHBUN CONCEPTS
Plano, TX
Sales Manager
Nov 2007 – Jun 2013
RUTH’S CHRIS STEAK HOUSE
Nashville, TN
Office Manager/Hostess Coach
Dec 2006 – November 2007
THE REHAB DOCUMENTATION COMPANY
Nashville, TN
Regional Enterprise Sales Representative
Aug 2005 – December 2006
FLEMINGS PRIME STEAKHOUSE AND WINE BAR
Birmingham, AL
Hospitality Coordinator
Oct 2004 – July 2005
SOURCE MEDICAL SOLUTIONS
Birmingham, AL
Billing and Compliance Manager
Feb 2003 – Feb 2005
Product Support Manager
Oct 2000 – Feb 2003
REHAB ASSOCIATES
Montgomery, AL
Office Manager
Sept 1996 – Oct 2000
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