TRESSA MONROE
San Antonio,TX
Summary
Experienced and resourceful Associate Director of Regulatory Affairs with a strong skill set in ensuring regulatory compliance for company HCT/P products and Medical Devices. Proficient in collecting, collating, and evaluating information to insure regulatory compliance of the quality management system. Demonstrated success in obtaining state licenses for Tissue Bank, while strictly adhering to FDA regulations and AATB Standards. Detail-oriented and diligent professional, adept at coordinating and delivering regulatory guidance and recommendation.
Overview
21
21
years of professional experience
Work History
Associate Direct of Regulatory Affairs
Extremity Care
04.2024 - Current
- Supporting Executive Management in oversight of all regulatory matters, to include the regulatory framework, submissions, and functions ensure that the quality management system and operational functions are compliant with the FDA and state regulation, AATB Standards, and other applicable regulations.
Regulatory Affairs Manager
Extremity Care
11.2023 - 04.2024
- Managing the Regulatory Affairs department and function to ensure regulatory compliance of the quality management system.
Senior Regulatory Affairs Associate
Extremity Care
05.2023 - 11.2023
- Assessing and ensuring regulatory compliance of the quality management system. Development of regulatory documents; planning, tracking, executing, and archival of regulatory submission; performing review of the regulatory landscape; and regulatory affairs project management in support of designated activities.
Regulatory Affairs Associate
Extremity Care
11.2022 - 05.2023
- Assessing and ensuring regulatory compliance of the quality management system.
Quality Assurance Associate
Extremity Care
06.2022 - 11.2022
- Assessing compliance of the quality management system regulatory requirements, review/ approve/ reject tissue, and discontinue processing and/or release of tissue when deviations from SOP warrants.
QUALITY SUPERVISOR
BIOBRIDGE GLOBAL
11.2020 - 06.2022
- Support and lead Quality Control staff through daily functions to provide donated HCT/P to further improve lives
- Collaborate with operational staff to drive innovation around process and product development.
QUALITY ASSOCIATE
BIOBRIDGE GLOBAL
12.2016 - 11.2020
- Performed daily functions of quality control and review of tissue and cellular therapy products
- Review of environmental monitoring and supporting back-room tasks for accrediting and regulatory audits.
LABORATORY TECHNOLOGIST
QUALTEX LABORATORIES
01.2005 - 12.2016
- Perform, track and report automated testing on blood and plasma for infectious diseases
- Maintain and calibrate instruments for accuracy.
Education
BATCHELORS OF SCIENCE (BIOCHEMISTRY) -
ST. MARY'S UNIVERSITY
05.2004
Skills
- Maintain accurate record review for recovered cadaveric tissue, acquisition of birth tissue and collection of cellular therapy products
- Tailor communication and directives to all stakeholders
- Develop SOPs and training curriculum for operational staff
- Ability to lead a team through audits from accrediting and regulatory bodies such as AATB, AABB, NMDP and FDA
- Multi-task through daily review of maintenance documents and environmental monitoring records
- Assess competing priorities and deliver records consistent with required standards/SOPs
City
San Antonio
State
TX
Zip
78247
Street
3426 Pecan Gap
Timeline
Associate Direct of Regulatory Affairs
Extremity Care
04.2024 - Current
Regulatory Affairs Manager
Extremity Care
11.2023 - 04.2024
Senior Regulatory Affairs Associate
Extremity Care
05.2023 - 11.2023
Regulatory Affairs Associate
Extremity Care
11.2022 - 05.2023
Quality Assurance Associate
Extremity Care
06.2022 - 11.2022
QUALITY SUPERVISOR
BIOBRIDGE GLOBAL
11.2020 - 06.2022
QUALITY ASSOCIATE
BIOBRIDGE GLOBAL
12.2016 - 11.2020
LABORATORY TECHNOLOGIST
QUALTEX LABORATORIES
01.2005 - 12.2016
BATCHELORS OF SCIENCE (BIOCHEMISTRY) -
ST. MARY'S UNIVERSITY
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