Karla Fields Email & Phone Number

Remote

Remote

Bloomington, Indiana Area

Bloomington, Indiana Area

Batesville, Indiana

Serving as the Manager for Corporate Field Corrective Actions globally. Facilitate training and on-boarding of new entities to the process, solve and escalate challenges through the entire field action process, staffing of field actions for new entities, global process improvement, Regulatory Filings and issue closures on all open Field Corrections globally. Manage the process and the Corporate Field Action Committee Leadership Team.

Itasca, Illinois

Provide Regulatory support for assigned product lines on labeling and marketing communication reviews as necessary to support new launches and sustaining maintenance as required. Additionally create regulatory submissions and provide regulatory reviews and responses for global submissions and registrations.

Mchenry, Illinois

Provide Regulatory support for assigned product lines on labeling, marketing communication reviews and FDA submissions/responses as needed.

Abbott Nutritional - Lake Forest

Provided Regulatory leadership for device connection requirements in 15 countries for Abbott Nutrition including labeling reviews and registrations.

Madison, Wisconsin Area

*Managed six product lines – Class II Medical Anesthesia Devices and Vaporizers*Created 510k’s for the US, Technical Files for the EU and MDL’s for Canada (143 Countries)*Produced International Registrations on all devices (143 countries)*Approved all design changes, marketing materials and labeling*Provided Regulatory leadership for a $400M business unit*Reviewed as the Regulatory Lead all supplier transfers, refurbishment/ remanufactured and new product introductions for assigned product variants (12) and Class III products as assigned*Served on two Change Control Boards (Anesthesia and Vaporizers)*Ability to interpret FDA regulations, ICH/ISO/ANSI standards and US/EU guidelines*Completed Internal Auditor Certification and Internal Audits as assigned

Tampa/St. Petersburg, Florida Area

Top closer of the year, Reviewed loan documents included in file to ensure closing/applicable law to loan requirements were met, Ordered wires thorough corporate office for processing through Federal Reserve & Provide funding authorization to Title Companies and Closing Attorneys

Tampa/St. Petersburg, Florida Area

*Managed client account relationships with Office of President Accounts*Responsible for $3M budget (encompassing advertising, facility loc. and contractors)*Interviewed candidates for open job orders*Created green initiative in onboarding packages saving company $60K yearly*Cultivated employee leadership and training programs*Monitored all ULP claims*Administered FMLA policies for internal full time employees*Administer all exit interviews and termination paperwork for 150 consultants

*Managed ancillary product line – Class I and II accessory devices*Worked on project teams for FDA responses of Class II and Class III Medical Devices *Prepared supplements and notifications for design changes to PMA’s*Created annual reports for PMA’s to FDA*Provided regulatory leadership on product registrations for 83 countries *Served on project teams to develop regulatory position papers and technical summaries*Tracked materials and manufacturing changes that impacted FDA and CE Mark files*Managed international products in accordance with import and export law

Round Lake, Il

Create and maintain SOP database system, Conducted Lot Sampling/Lot Monitoring programs, Assisted in Gap Analysis for Class II Medical Devices, Administrated comparison study of Plastics Master Files with PL Cards, Assisted in preparing and processing Regulatory Submissions

Rolling Meadows, Il

*Increased territory revenue by 20% in first six months*Provided staffing for two Account Executives*Conducted contract negotiations as appropriate*Instituted marketing standards within the organization*Produced job descriptions and review process for Account Executives*Created spiffs & bonus structure for territory Account Executives

Rosemont, Il

*Conducted presentations to Employees and Management as appropriate*Staffed for two Account Executives*Increased active client account base by 50%*Created and administered sales incentives for the team*Train and supervise all HR staff*Determine “at risk” employees and conduct all “at risk” meetings*Administered FMLA, FLSA and LOA compliance programs*Administer/Create all exit interviews and termination paperwork*Maintain training budget for each employee*Create and administer all CDAP’s (Career Development Action Plans)*Administrate and counsel on reviews within the organization*Served as Corporate Benefits Manager for Insurance, Unions, 401(K) and Payroll issues

Schaumburg, Il

Bachelor'S Of Science, Business Management, 3.93

Activities and Societies: The National Society of Collegiate Scholars (NSCS) Delta Mu Delta Honors Society Summa Cum LaudeCompleted, 2021.

General Management Certificate