KELLY JO DAVIS
Regulatory Affairs
Gobles,MI
Summary
Dynamic regulatory affairs professional with extensive experience at Stryker Instruments, excelling in project management and stakeholder communication. Proven track record in enhancing compliance through strategic planning and effective training delivery. Adept at leading cross-functional teams to achieve operational excellence and drive process improvements, ensuring adherence to regulatory standards.
Overview
19
19
years of professional experience
1
1
Certification
Work History
Staff Regulatory Affairs, External Audit Lead
Stryker Instruments
12.2021 - Current
- Lead preparation, engagement, training, logistics, and communication for external audits.
- Collaborated with cross-functional teams to address regulatory issues.
- Conducted training sessions on regulatory requirements for staff members.
- Updated in-depth trackers of approvals and submissions.
- Facilitated communication between internal departments and external stakeholders.
- Led audit teams to assess compliance with internal controls and regulations.
- Coordinated training sessions for staff on audit best practices and methodologies.
- Liaised with auditors to complete annual audits and maintain compliance.
- Cross-trained employees, enabling completion of priority tasks during personnel absences.
- Ensure compliance with regulations and department policies during external audits.
- Collaborate across business areas to drive audit success.
- Train and coach audit support team members for enhanced performance.
- Document and communicate the results of external audits effectively.
- Proactively identify and manage ownership of audit risks.
- Coordinate significant change notices with notified bodies to ensure compliance.
- Standardize global audit preparation processes for planned and unplanned audits.
Senior CAPA Specialist/Business Process Owner
Stryker Instruments
12.2016 - 12.2021
- Enhanced customer experience through process and product quality improvements.
- Built a sustainable and scalable quality organization via CAPA project management.
- Facilitated 4D project training to improve operational efficiency.
- Developed strategic partnerships globally to drive innovation and collaboration.
- Served as NC/CAPA process owner, ensuring compliance and effectiveness.
- Presented quality metrics to leadership during monthly and bi-monthly meetings.
- Supported audit preparation and execution to meet regulatory requirements.
- Managed project teams throughout CAPA processes for successful outcomes.
- Facilitated communication between departments to enhance workflow efficiency.
- Coordinated with other departments to ensure efficient workflow processes.
- Implemented strategies to take advantage of new opportunities.
- Led cross-functional teams to streamline process improvements and enhance operational efficiency.
- Coordinated training sessions for staff on new procedures and best practices.
- Managed multiple projects simultaneously ensuring timely completion within budget constraints.
- Performed root cause analysis to identify underlying issues affecting efficiency and effectiveness of processes.
- Provided training on procedures and best practices to staff members.
- Collaborated with other departments to develop new processes or modify existing ones as needed.
- Communicated regularly with senior management regarding status updates and progress made towards goals.
Regulatory Affairs Compliance Specialist
Stryker Instruments
12.2012 - 12.2016
- Provided comprehensive information for all product field action phases to business and Notified Bodies.
- Collaborated with cross-functional teams.
- Managed documentation related to compliance audits and investigations efficiently.
- Monitored internal processes for adherence to established compliance guidelines.
- Provided guidance on ethical practices and regulatory requirements across departments.
- Assisted in the preparation of reports for regulatory agencies as required.
- Maintained accurate records of all activities related to compliance monitoring.
- Coordinated with various departments within the organization to ensure adherence to established standards.
- Assisted in developing strategies for improving overall compliance performance.
- Provided support to department by assisting with special assignments and projects.
- Responded promptly to inquiries from government agencies regarding regulatory issues.
- Participated in meetings between senior leadership teams to discuss any potential violations or concerns about regulatory issues.
- Planned, executed, and monitored global recalls to ensure compliance.
- Coordinated approval and issuance of field action notices and FDA recall checklist.
- Communicated with FDA regarding potential advisory notices.
- Monitored Domestic, International, and Sales Sample field action updates for accuracy.
- Delivered regulatory guidance to internal and external stakeholders.
- Led Trackwise module for Stryker Instruments PFA to enhance tracking efficiency.
Med-Ed Coordinator
Stryker CMF
12.2009 - 12.2013
- Developed process for managing sales samples and product returns.
- Tracked shipments for sales training and educational events.
- Conducted daily cycle counts to maintain inventory control.
- Assisted in training new team members on operational procedures.
- Collaborated with sales and marketing teams to support product launches.
- Organized logistics for team events, ensuring resource availability.
- Maintained accurate inventory records to facilitate timely procurement.
- Facilitated communication between departments to resolve issues efficiently.
Line Lead/Personal Trainer
Stryker Medical
09.2006 - 12.2009
- Oversaw daily production operations to ensure efficiency and quality standards.
- Trained and mentored team members on best practices and safety protocols.
- Implemented process improvements that enhanced workflow and reduced downtime.
- Coordinated with management to align production goals with company objectives.
- Monitored inventory levels to maintain optimal stock for uninterrupted operations.
- Developed and maintained standard operating procedures for team consistency.
- Assisted in training new employees and implementing procedural changes.
- Trained and monitored line associates to perform proper assembly techniques, apply best practices and comply with safety procedures.
- Trained new employees on production line processes, ensuring a smooth transition into their roles and maintaining high performance standards.
- Followed daily production schedules for organized and on-time deliveries.
- Monitored inventory levels closely, coordinating with procurement teams to replenish stock as needed without causing delays in the production process.
- Implemented process improvement initiatives to increase productivity and quality standards.
- Managed daily production schedules to meet customer demands while minimizing overtime costs.
- Liaised with engineering team to troubleshoot and resolve machinery issues quickly.
Education
PMP Masters Certification - Project Management
PMT Institute
04-2015
No Degree - Project Management
ESI International
01-2015
Graduate Certificate - Medical Devices, Regulatory Affairs
Northeastern University
12-2014
Bachelor of Arts - Human Resources Management
University of Phoenix
Tempe, AZ05-2012
Skills
- Project management and audit oversight
- Stakeholder communication and engagement
- Public speaking and presentation
- Strategic planning and execution
- Process improvement methodologies
- Team collaboration and synergy
- Problem solving and analysis
- Effective training delivery
- Leadership and team guidance
- Active listening skills
- Time management techniques
Certification
- Certified Lead Auditor ISO/MDSAP Certification, OMNEX, 12-2022
Timeline
Staff Regulatory Affairs, External Audit Lead
Stryker Instruments
12.2021 - Current
Senior CAPA Specialist/Business Process Owner
Stryker Instruments
12.2016 - 12.2021
Regulatory Affairs Compliance Specialist
Stryker Instruments
12.2012 - 12.2016
Med-Ed Coordinator
Stryker CMF
12.2009 - 12.2013
Line Lead/Personal Trainer
Stryker Medical
09.2006 - 12.2009
PMP Masters Certification - Project Management
PMT Institute
No Degree - Project Management
ESI International
Graduate Certificate - Medical Devices, Regulatory Affairs
Northeastern University
Bachelor of Arts - Human Resources Management
University of Phoenix