Director, Regulatory Compliance (Class I and II Medical Devices/OTC Drugs) at Compass Health Brands Corp. (2022-02 – Present)
Recruited into this role to create and develop Regulatory Compliance Department to address organizational needs due to growth (reporting to Sr. VP, Operations)
- Regulatory oversight of New Product Development/Change Control process, including regulatory pathway strategies and labeling approvals; realignment of corporate Quality Management System to ensure compliance with new FDA QMSR and EU MDR; oversight of complaints/adverse event reporting/post-market surveillance processes
- Leading and developing 4-person team using a transformational coaching approach, fostering accountability, developing team leaders and facilitating team success within a lean, high-pressure environment
- Creation, implementation and management of Risk Management team/processes and Post-Market Surveillance team/processes; significant reduction in complaints due to this new process, including 55% reduction in serious injuries and 44% reduction in user errors
- FDA Management Representative for organization – successfully managed 2022 FDA and Health Canada inspections and required minor remediations; FDA Recall coordination and management; CAPA Management
- Cross-functional team leadership and project management for supplier product recall; on-going project management of risk management/post-market surveillance team tasks and responsibilities
Principal Consultant/Owner at Q-Metrics, LLC (2019-05 – 2022-02)
- Extensive experience in successful FDA 483 remediations and regulatory agency interactions (Q-Subs, 510k submissions); 100% success rate for Quality Management System design and implementation (several clients' FDA inspections resulted in no findings while all others resulted in only minor findings; successful MDSAP certification audits)
- Project Manager - International UDI Implementation project (for Becton Dickinson)
Manager, Quality and Regulatory Compliance at Compass Health Brands Corp. (2015-04 – 2019-10)
- Regulatory representative for New Product Development team, responsible for ensuring regulatory compliance for design control activities; Development and presentation of FDA Annual Management Review meetings; Internal QMS audit performance and management; Management of regulatory licensing and registrations (FDA, Health Canada Device Licensing and MDEL, EU Technical Files, WEEE and Packaging registrations/reporting and Board of Pharmacy Manufacturer/Distributor licensing)
- Multi-site complaint management/global adverse event reporting process in compliance with 21 CFR 820 and 21 CFR 803, Health Canada and EU MDR regulations
- Product and process change control programs
- Labeling compliance and control process, including regulatory/claim substantiation reviews/approvals
- Sourcing, implementation and oversight of corporate electronic training program
- Internal and third-party CAPA process
- Leading and developing 2-person team fostering accountability, developing team leaders and facilitating team success within a lean, high-pressure environment
- Co-lead for FDA and Health Canada inspections, successfully navigating inspection processes and addressing needed remediations from findings including remediation of Quality Management System to address 2015 FDA inspection 483 findings
- Lead Project Manager of cross-functional, multi-site UDI Implementation team; Cross-functional team leadership and project management for several product recalls
- Regulatory representative for creation and implementation of product quality risk assessment process; Review and approval of monthly product quality risk assessments
Regulatory Affairs Specialist (Medical Device) at Invacare
Quality Assurance Specialist II (Pharmaceutical) at Boehringer Ingelheim
Quality Assurance Group Leader (ASQ Certified Quality Auditor) at Amresco, Inc.
Regulatory Compliance Auditor (Pharmaceutical) at Boehringer Ingelheim
