Quality Control Management

Idrissa Sparks, MBA

Mount Vernon, New York

Email: *************@*****.***

Objective

Regulatory Affairs Associate

Summary of Qualifications

. Experienced in U.S and international product registrations,

submissions, and change notifications.

. Experienced in preparing, submitting, and filing U.S and

international certifications and other legal documents.

. Proficient in orchestrating government agency and Company

audits.

. Proficient in supporting complex deadlines, identifying

priorities, and resolving issues.

. Proficient in product registration management

. Excellent team leader with cross functional experience.

Career Experience

Regulatory Affairs Specialist: April 5, 2010 - Present, Siemens Healthcare

Diagnostics Inc., Tarrytown, NY

. Responsible as a regulatory member in the preparation and

submission of 510k's, PMA's, technical files for EU registrations and

Canadian applications. Also responsible for other worldwide

registrations.

. Responsible for maintaining FDA submissions, product change

notification to countries, tracking and fulfilling requests for

information and documents for global registrations.

. Responsible for creating databases, reports, and using other

global software applications (i.e., SharePoint and Document Management

Systems) to support efficiency of daily operations and product

registrations.

. Responsible for preparing international registration documents

such as Letters of Authorization, Product Compositions, Certificates

of Exportability, Certificates to Foreign Government, and Declarations

of Conformity.

. Responsible for maintaining quality control certifications,

monthly reports, global contacts, and all regulatory files.

. Manages the compilation of regulatory documents to support

government agency and Company audits.

. Responsible for labeling review to support global product

registrations.

. Interacts with various departments such as marketing, research

and development, and manufacturing regarding product registrations and

changes.

Executive Assistant / Member Representative: Nov. 2008 - June 2009, NEMRA,

Tarrytown, NY

. Managed all executive level administrative tasks including

maintaining files, scheduling meetings and conference calls, and

fulfilling member requests for information.

. Assisted in preparation of yearly conference.

. Adeptly handled incoming communications and responded to

requests on a timely basis.

. Developed a quality records management system for documentation

and efficient processing.

Administrator: Feb. 2003 - August 2006, Baby Girl Inc., Mount Vernon, NY

. Scheduled off-site meetings by contacting participants, sending

notices, making appointments, conducting interviews, and notifying

appropriate parties of the time and location.

. Coordinated internal meetings by preparing agendas and other

written materials.

. Processed database inquiries and adeptly utilized spreadsheet

and presentation software for multiple, deadline-oriented projects,

and completed expense account documentation and filing with

accounting.

Education

Iona College - Hagan School of Business, New Rochelle, NY

Masters Degree - Business Administration / E-Commerce Certificate (May

2010)

Concordia College - Bronxville, NY

Bachelor of Science - Business Administration (May 2008) Borgen Prize in

Business

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