Shelby Becker
Indianapolis
Summary
Thorough team contributor with strong organizational capabilities. Experienced in handling numerous projects at once while ensuring accuracy. Effective at prioritizing tasks and meeting deadlines. Collaborate incline to promote quality data with primary though to risk and determining gaps in the process.
Overview
11
11
years of professional experience
1
1
Certification
Work History
Quality and Regulatory Compliance Specialist II
TRIMEDX
12.2022 - Current
- Championed process improvements within the company by identifying outdated practices and recommending innovative solutions that align with current regulatory requirements.
- Provided guidance on corrective action plans following internal or external audit findings to remediate identified issues promptly effectively.
- Supported external audits by providing necessary documentation, addressing inquiries, and implementing corrective actions as needed.
- Collaborated with cross-functional teams to develop best results to deliver improved data, processes, and efficiency.
- Developed training materials and conducted workshops to educate employees on understanding processes and best practices.
- Reviewed descriptions and model data to assess compliance with FDA regulations and standards.
- Conducted gap analyses to identify areas requiring improvement or enhancements within existing compliance frameworks.
Quality and Regulatory Affairs Associate
Berlin Heart Inc.
05.2015 - 07.2022
- Compiled and maintained regulatory documentation systems and explained policies, regulations and procedures as well as oversaw the QMS system.
- Created and implemented the risk management system according to ISO 13485.
- Evaluated changes to policy and procedures to determine amendments and implement/oversaw changes to ensure compliance with regulations.
- Monitored and drafted reports for adverse events and for medical device reporting.
- Addressed non-conformances and change controls, including creating and monitoring CAPA.
- Prepared and oversaw internal audits and regulatory inspections according to ISO 13485 and 21 CFR.
- Researched new regulatory requirements to implement changes and launch resulting organizational changes.
- Authored internal reports for audits, submitted HDE/IDE applications and amendments to regulatory agencies.
- Managed the training database and matrices of employees.
Quality Associate
Eli Lilly Through Jolie Technical Services
08.2014 - 04.2015
- Notified supervisors about production problems and helped identify and correct concerns.
- Documented inspection information and compiled data into reports for dissemination to management.
- Performed independent auditing reviews of records and reports prior to final release of documentation for completeness and accuracy.
Associate Data Manager
Covance through Aerotek
05.2014 - 08.2014
- Assisted with upholding and fortifying digital security systems to protect valuable and confidential information.
- Generated and managed ad hoc requests for clinical reports, supporting strategic decision-making.
- Built and managed queries and analysis reports according to each study protocol and maintained strict confidentially of each data set.
Education
Master of Science - Clinical And Regulatory Affairs
Grace College
05.2014
Bachelor of Science - Biology With Minors in Chemistry And Mathematics
Saint Mary-of-the-Woods College
Terre Haute, IN05.2013
Skills
- Pre-Market and Post-Market Submissions
- Medical Device Reporting
- Training & Development
- Planning & Organizing
- Data Management
- Material Review
- Information Verification
- Technical Guidance
- CAPA management
- Documentation review
Certification
- ISO 13485:2016 Internal Auditor
Timeline
Quality and Regulatory Compliance Specialist II
TRIMEDX
12.2022 - Current
Quality and Regulatory Affairs Associate
Berlin Heart Inc.
05.2015 - 07.2022
Quality Associate
Eli Lilly Through Jolie Technical Services
08.2014 - 04.2015
Associate Data Manager
Covance through Aerotek
05.2014 - 08.2014
Bachelor of Science - Biology With Minors in Chemistry And Mathematics
Saint Mary-of-the-Woods College
Master of Science - Clinical And Regulatory Affairs
Grace College
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