Regulatory Affairs Associate Resume Example St. Jude Medical

REGULATORY AFFAIRS ASSOCIATE

Professional Summary

Proven ability to effectively communicate with managers and clients. Able to determine and implement documentation or procedural needs. Self directed, flexible, with strong team leadership skills to consistently meet and exceed identified goals and objectives. Effective communication and organizational skills. Ability to work well with little or no supervision, able to work well under time constraints.

Core Qualifications

Microsoft Office, GTS SAP (PRD, ECC, BW)
Key Skills: Communication, Project Management, Organization, Customer Relations

Experience

Regulatory Affairs Associate
February 2009 to CurrentSt. Jude Medical － Plano,, TX

Release GTS-SAP licenses of regulatory submission approvals for new products including FDA, Investigational Device Exception (IDE), Pre-Market Approvals (PMA) and European Conformite Europene (CE) Marketing
Knowledge of the following regulatory requirements preferred: Quality System Regulations (QSRs), Good Manufacturing Practices (GMPs), Therapeutic Goods Administration (TGA) - Australia,
Release any blocked licenses upon Regulatory approval after products are released to market for distribution.
Submit 510K/PMA numbers to FDA to receive device listing numbers
Recertification Submission for EC Certification

Training Analyst
October 2006 to January 2009Alcatel-Lucent － Plano, TX

Process all customer and employee registrations and create customer orders as required for product specific training event.
Enter new classes into database and assign resources.
Record employee attendance and grades.
Negotiate price quotes for vendors and customers.
Prepare weekly billing reports, invoices and purchase orders.
Participate in database audit and clean-up projects as requested.

Staff Specialist
January 2006 to July 2006Verizon Business － Plano, TX

Perform in-depth analysis of the Satellite Solutions Group's internal processes and provisioning tools.
Document processes and procedures according to ISO 9001:2000 standards.
Conduct training sessions regarding ISO 9001:2000 certification.
Provide proactive recommendations to management regarding process development/improvement, business process documentation, and implementation planning and issue resolution.
Provide flexibility in dealing with multiple internal and external systems, projects and organizations, and project management tools.

Provider Relations Representative
October 2005 to January 2006TrailBlazer Health Enterprises － Dallas, TX

Develop, prepare, and ensure quality materials for all presentations and exhibit booths.
Conduct, facilitate, and attend meetings with providers and/or provider groups as well as internal staff members.
Maintain a thorough knowledge of Section 1011 claims and correspondence policies, procedures and related guidelines to conduct training sessions regarding changes and coverage issues.

Medical Editor
January 2003 to October 2005Physician Education Resource － Dallas, TX

Proofread and edit cancer journal articles, written by oncologists, for discrepancies in data, grammar, syntax and style.
Research source references for accurate information.
Conduct thorough review of journals to meet the American Medical Association and PER guidelines.
Manage time effectively to meet publication deadlines while maintaining quality standards.
Manage and oversee the publication of Clinical Breast Cancer journal through its completion.
Submit galley and query correspondence to oncologists regarding their manuscript.

Label Editor
March 2002 to January 2003Abbott Diagnostic － Irving, TX

Proofread, reviewed, edited, and approved labeling change control documentation for consistency with similar or related product specifications that meet quality, regulatory, and FDA specifications.
Managed and oversee the change control packages for product labeling and ensuring documentation is appropriate.
Participated with new product teams for successful completion of assigned projects.

Documentation Specialist
February 1994 to August 2001Avaya Incorporated － Carrollton, TX

Documented processes, procedures, and specific customer requirements using IMI database.
Communicated with subject matter experts to document specified deliverables.
Coordinated the testing, editing, approval and publication of completed documentation.
Developed and maintained project deliverables such as Scope of Work, project plans, project team structure and contact lists.
Developed, designed, and published customer-based web sites for high profile clients including Bank One, American Airlines, AT&T, and Union Carbide.
Created and designed the company-wide IS3e software training manual.
Spearheaded national IS3e training for Florida, Colorado, and Texas offices.
Performed several MS Project administrative tasks.

Education

Bachelor of Science : English Literature, 2000University of North Texas － Denton, TX

Professional Affiliations

Technical Writing Certificate

Skills

Microsoft Office, MS Word, MS Excel, MS PowerPoint, MS Outlook, MS Projects, Project Management, Account Management, Client Relations, Customer Service, Problem Solving, Research, Reporting

Resume Overview

Companies Worked For:

St. Jude Medical
Alcatel-Lucent
Verizon Business
TrailBlazer Health Enterprises
Physician Education Resource
Abbott Diagnostic
Avaya Incorporated

School Attended

University of North Texas

Job Titles Held:

Regulatory Affairs Associate
Training Analyst
Staff Specialist
Provider Relations Representative
Medical Editor
Label Editor
Documentation Specialist

Degrees

Bachelor of Science : English Literature , 2000

Regulatory Affairs Associate Resume Example

Resume Score: 90%

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