Heather Strasser
Pittstown,NJ
Summary
Results-driven Regulatory Operations Specialist skilled in managing global UDI and BUDI data, ensuring compliance for over 1000 medical devices. Expertise in regulatory databases and cross-functional collaboration enhances operational efficiency and supports adherence to evolving global UDI regulations.
Overview
1
1
Certification
12
12
years of professional experience
Work History
REGULATORY OPERATIONS SPECIALIST
Integra Lifesciences Corporation
USA
01.2026 - Current
- Developed comprehensive training and FAQ documents for managing Unique Device Identification (UDI), Basic UDI (BUDI) data, FDA establishment licenses, and device listings in FDA FURLS, GUDID regulatory databases, Regulatory Information Management System (RIMS), and AGILE Enterprise Management System (ERP).
- Trained 3 backup personnel to ensure seamless continuity of responsibilities during leave or emergencies.
REGULATORY DATA MANAGEMENT SPECIALIST
Integra Lifesciences Corporation
USA
08.2024 - 03.2026
- Managed global UDI and BUDI data in GUDID, FURLS, RIMS, and AGILE ERP system for over 1000 existing devices, creating new UDIs and BUDIs to ensure compliance.
- Collaborated cross-functionally with other departments to ensure device UDI and BUDI data and label compliance and creation of new UDI's and BUDI's.
- Understood, executed, and maintained the requirements of UDI regulations for ongoing global compliance (e.g., FDA GUDID, FURLS, EUDAMED, GS1, and product labeling).
- Managed and maintained the USA Device Establishment Registration and Device Listings data in the FDA FURLS database for over 1000 products and created new device listings.
- Analyzed data across multiple information systems, identified discrepancies, and coordinated with regulatory leads to resolve issues affecting product lines or regions.
- Provided regulatory support to company functional units such as customs, quality, and supply chain and adhered to and updated relevant Standard operating procedures (SOPs) and work instructions.
- Worked within the RIMS system to complete requests for creating new and updating existing registration information for various countries and creating submission document records for historical submissions.
- Developed and maintained SOPs and work instructions for global UDI, BUDI, FDA device listings, and establishment registrations in RIMS, FDA GUDID, and FURLS databases.
- Kept apprised of new GS1, UDI, and BUDI regulations, standards, policies, and guidance issued by relevant regulatory authorities that may affect the company.
- Used the ServiceNow IT ticketing system to interact cross-functionally to complete and close RIMS requests.
- Established and co-led a resource group for disabled employees, aimed at promoting inclusivity and addressing their unique needs.
- Collated resources for 30+ disabilities into disability and intersectional resource libraries, hosted monthly stakeholder update meetings and quarterly member meetings, and worked with the company HR to improve internal practices to be more inclusive for disabled individuals.
REGULATORY AFFAIRS
Integra Lifesciences Corporation
USA
08.2023 - 08.2024
- Developed private label product database to track regulatory information for 800+ products, enhancing compliance oversight.
- Corresponded with external and internal private label partners to gather information and submit documentation for regulatory requests, ensuring timely compliance.
- Worked cross-functionally to complete regulatory projects and requests related to private label products.
- Updated and assisted with the maintenance of the EU design dossiers/technical files for the private label products.
- Maintained regulatory product files to ensure alignment with regulatory requirements and facilitate audits.
- Reviewed change controls and provided regulatory support for private label products.
- Worked with the Regulatory Information Management System (RIMS) system to complete requests for creating new and updating existing registration information for various countries.
- Developed and created a private label partner request form and tracking system.
- Created procedures for managing private label partner requests, the product database, and the shared inbox created for requests.
ASSOCIATE MICROBIOLOGIST
Actalent serving Ethicon, Inc.
USA
01.2020 - 08.2023
- Conducted Zone of Inhibition (ZOI) experiments to evaluate antimicrobial effectiveness. and log attachment experiments. Interpreted results as required.
- Updated and authored new and old SOPs to current standards.
- Applied GLP/GDP knowledge through the review of raw data.
- Implemented a new process for archiving and organizing department raw data, improving accessibility and compliance.
- Led documentation efforts for laboratory equipment and supply relocation, ensuring seamless transition and operational continuity.
- Created an inventory tracking and catalog database, enhancing resource management and retrieval efficiency.
- Coordinated with multidisciplinary teams, CROs, and quality assurance to support project plans.
- Performed hands-on training of 5 new laboratory associates on department procedures.
MICROBIOLOGIST LAB ANALYST II
Nelson Laboratories
USA
05.2018 - 12.2020
- Conducted routine USP71 and AAMI/ANSI/ISO 11137 sterility tests on pharmaceutical and medical device products in ISO Class 5 clean room, ensuring compliance with regulatory standards.
- Generated final reports for clients using in-house system, delivering accurate documentation of test results and findings.
NECROPSY TECHNICIAN II
Envigo++++
USA
01.2015 - 08.2018
- Collected tissue samples of various species in adherence to SOPs and protocols, contributing to reliable research outcomes.
- Recorded detailed observations of tissues collected via Pristima and Xybion programs.
- Documented and corrected deviations, preparing data books for report writer group to ensure compliance and accuracy.
- Led project to develop suite of dynamic input forms in Microsoft Excel for laboratory use, enhancing accuracy and efficiency.
Education
Master of Business & Science -
Rutgers University
USA01-2022
Bachelor of Science -
Delaware Valley College
USA01-2013
Skills
- UDI and BUDI management & regulations
- Regulatory compliance
- FDA device establishment registration
- Data management principles management
- RIMS expertise
- GLP, GMP, and GDP knowledge
- Data management
- Data management
- Project management
- Process improvement
- Process documentation
- Analytical thinking
- Problem-solving skills
- Microsoft Office
- SharePoint proficiency
- Tableau expertise
- Power BI proficiency
- Team collaboration skills
- Cross-functional teamwork
- Attention to detail
- Organizational skills
- Adaptability and flexibility
- Scientific research
Personal Information
Title: Regulatory Operations Specialist
Certification
- GS1 Foundations Virtual Classroom Certificate
- GS1 Standards for U.S. FDA UDI Online Certificate
Timeline
REGULATORY OPERATIONS SPECIALIST
Integra Lifesciences Corporation
01.2026 - Current
REGULATORY DATA MANAGEMENT SPECIALIST
Integra Lifesciences Corporation
08.2024 - 03.2026
REGULATORY AFFAIRS
Integra Lifesciences Corporation
08.2023 - 08.2024
ASSOCIATE MICROBIOLOGIST
Actalent serving Ethicon, Inc.
01.2020 - 08.2023
MICROBIOLOGIST LAB ANALYST II
Nelson Laboratories
05.2018 - 12.2020
NECROPSY TECHNICIAN II
Envigo++++
01.2015 - 08.2018
Master of Business & Science -
Rutgers University
Bachelor of Science -
Delaware Valley College