REGINA KLAPPERICH
Summary
Dynamic professional with a diverse background spanning healthcare, medical device manufacturing, and regulatory compliance. Skilled in integrating insights across disciplines to drive operational excellence and regulatory adherence. Exceptional customer service acumen enhances the ability to communicate complex compliance requirements effectively. Adept at optimizing processes to align with evolving industry standards..
Overview
19
19
years of professional experience
Work History
REGULATORY AFFAIRS SPECIALIST
IMMY INC.
07.2021 - 05.2023
- Timely preparation and maintenance of technical documents for regulatory submissions
- Multiple registrations completed in countries of Brazil, Taiwan, Ethiopia, India and others
- Reviewed shipping restrictions in relation to product regulatory status and works with Sales and Customer Service to ensure compliance
- Maintained a deep understanding of new and existing regulations that may impact products and processes
- Maintained knowledge of submission requirements and processes for multiple regulatory jurisdictions
- Explained regulations, procedures, and policies to all employees and stakeholders as necessary
- Assisted in reviewing labeling, promotional, legal, and technical documentation to assess compliance.
- Maintained and archived regulatory paperwork.
- Prepared and submitted regulatory file applications and supporting documentation.
- Prioritized project-related tasks to efficiently complete essential tasks.
- Represented company in manufacturing industry during communications with global regulatory agencies.
REGULATORY AFFAIRS TECHNICIAN - CTRP (Remote)
OUHSC STEPHENSON CANCER CENTER (SCC)
01.2020 - 07.2021
- Reviewed, registered, and maintained clinical studies and accruals for trials open at SCC, in the National Cancer Institute (NCI) Clinical Trials Reporting Program Database (CTRP).
- Conducted quality assurance checks in WCG/Velos and CTRP to identify outliers, missing and/or conflicting data, and addressed and rectified those discrepancies
- Aggregated and review clinical data including research protocols, regulatory documents and other documents related to CTRP and ClinicalTrials.gov from a variety of sources ensuring accuracy, timeliness, confidentiality, and security of data.
- Maintained existing clinical trials in CTRP and ClinicalTrials.gov including trial status updates, amendments, and ongoing IRB approvals per system requirements and institutional SOPs.
- Monitored data to identify problems and /or inconsistencies in trials and patient enrollment data to those trials; recommend corrective action and escalate as appropriate.
- Created, maintained, and updated work instructions, guidance documents in assigned program areas and work tasks.
VERIFICATION CLERK
NORMAN REGIONAL HOSPITAL
01.2015 - 01.2016
- Verified and pre-certified insurance coverage for outpatient procedures
- Contacted primary care physicians, Indian health services, or other agencies or care facilities when necessary to facilitate referral for services
- Worked collectively with other revenue cycle departments to perform duties related to insurance, coding, and medical necessity
- Pre-registered patients over phone for upcoming appointments.
COMPLIANCE SPECIALIST /RESOLUTIONS SPECIALIST / MEDICAL BILLER
180 MEDICAL INC.
01.2012 - 01.2015
- Conducted internal file verification audits on patient accounts to ensure compliance with all documentation requirements
- Conducted 50-100 external public and commercial health plan audits per week and completed all levels of insurance appeals
- Coordinated file verification findings with team managers to review and ensure corrections to meet compliance requirements
- Conducted monthly/quarterly reviews of public and commercial health plan programs to ensure continued compliance with requirements
- Researched and documented public health plan, commercial health plan, and federal and state laws, regulations, and requirements as needed
- Reviewed and analyzed monthly aging reports to detail past due receivables
- Resolved claim disputes through thorough analysis and judgment
- Re-filed outstanding claims to insurance policy, and reviewed denied claims and appealed, if necessary, criteria were on file to support claim payment
- Coded products with correct HCPC coding, data entry of orders into computerized billing systems
- Electronically submitted claims daily to Medicare, Medicaid, and commercial insurance companies and resolved claim issues
- Communicated with customers regarding billing and assisted in collections and processed credit card payments.
FITNESS SPECIALIST/ RECREATION ASSISTANT GS-05
GERRITY FITNESS CENTER
01.2007 - 01.2011
- Provided facility and program information and courteous customer service
- Various customer service duties including telephone and receptionist services; receiving and relaying incoming and outgoing telephone, intercom, and electronic messages
- Inspected indoor and outdoor recreation sports facilities and equipment for security and general conditions
- Developed and conducted briefings for the Air Force Enlisted Spouses Club
- Safety Representative for the facility
- Responsible for making sure staff know and understand VPP (Voluntary Protection Program)
- Evaluated fitness testing at Fitness Assessment Cell and calculated scores for each component of testing.
MEDICAL RECORDS CLERK; CLERK II
NM ORTHOPEDICS
01.2006 - 01.2007
- Handled dual functions, initiated medical charts, and worked closely with front office personnel, and provider's staff
- Prepared charts for scheduled patients, ensured progress notes were updated
- Prepared charts as needed for special audits, peer review, refill requests
- Inserted all medical record correspondence into the patients' file needed for review by the provider as per policies and procedures in accordance with licensing and regulatory requirements or as instructed by the clinical staff.
MEDICAL RECORDS CLERK; CLERK II
DESERT ORTHOPEDICS
01.2005 - 01.2006
- Handled dual functions, initiated medical charts, and worked closely with front office personnel, and provider's staff
- Prepared charts for scheduled patients, ensured progress notes were updated
- Prepared charts as needed for special audits, peer review, refill requests
- Inserted all medical record correspondence into the patients' file needed for review by the provider as per policies and procedures in accordance with licensing and regulatory requirements or as instructed by the clinical staff.
MEDICAL RECORDS CLERK; CLERK II
LOVELACE HEALTH SYSTEMS
01.2004 - 01.2005
- Handled dual functions, initiated medical charts, and worked closely with front office personnel, and provider's staff
- Prepared charts for scheduled patients, ensured progress notes were updated
- Prepared charts as needed for special audits, peer review, refill requests
- Inserted all medical record correspondence into the patients' file needed for review by the provider as per policies and procedures in accordance with licensing and regulatory requirements or as instructed by the clinical staff.
Education
Bachelor of Science - Health Sciences
PURDUE GLOBAL
West Lafayette, IN07.2026
ORAQ REGULATORY AFFAIRS TRAINING PROGRAM - Clinical Trials
DUKE UNIVERSITY
Online09.2023
PROJECT MANAGEMENT FUNDAMENTALS CERTIFICATE -
MOORE NORMAN TECHNOLOGY CENTER
08.2022
RATON HIGH SCHOOL
12.2004
Skills
- Attention to detail of Complex Data Sets
- Analytical abilities
- Excellent professional communication
- Outstanding people skills
- Problem-solving
- Critical thinking
- Team Oriented
- Medical terminology
- Microsoft Word, Excel, and Outlook
- Dependable
Timeline
REGULATORY AFFAIRS SPECIALIST
IMMY INC.
07.2021 - 05.2023
REGULATORY AFFAIRS TECHNICIAN - CTRP (Remote)
OUHSC STEPHENSON CANCER CENTER (SCC)
01.2020 - 07.2021
VERIFICATION CLERK
NORMAN REGIONAL HOSPITAL
01.2015 - 01.2016
COMPLIANCE SPECIALIST /RESOLUTIONS SPECIALIST / MEDICAL BILLER
180 MEDICAL INC.
01.2012 - 01.2015
FITNESS SPECIALIST/ RECREATION ASSISTANT GS-05
GERRITY FITNESS CENTER
01.2007 - 01.2011
MEDICAL RECORDS CLERK; CLERK II
NM ORTHOPEDICS
01.2006 - 01.2007
MEDICAL RECORDS CLERK; CLERK II
DESERT ORTHOPEDICS
01.2005 - 01.2006
MEDICAL RECORDS CLERK; CLERK II
LOVELACE HEALTH SYSTEMS
01.2004 - 01.2005
Bachelor of Science - Health Sciences
PURDUE GLOBAL
ORAQ REGULATORY AFFAIRS TRAINING PROGRAM - Clinical Trials
DUKE UNIVERSITY
PROJECT MANAGEMENT FUNDAMENTALS CERTIFICATE -
MOORE NORMAN TECHNOLOGY CENTER
RATON HIGH SCHOOL
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