Heather Neely Email and Phone Number

Provides regulatory consulting services for areas that include global submissions, global strategy, equipment and process validation, auditing and audit preparation, training, quality system set-up and assessment per ISO 13485, 21 CFR 820, Regulation (EU) 2017/745, MDRs, change control and labeling

•Manage, organize, and maintain the Quality Assurance and Regulatory Compliance requirements in accordance with applicable domestic and foreign medical device regulations •Assist in establishing and reaching company’s goals and objectives by setting schedules, technical milestones and cost limitations•Supervise progress of assigned personnel to ensure that targets are met•Designated Management’s Representative, conducting and documenting periodic Management Reviews•Interact directly with FDA and Notified Body during on-site audits, recalls, and MDR reporting•Prepare FDA 510(k) submissions and Technical Documents for EU MDR regulations•Interface with Distributors for testing and international submission strategy/requirements•Maintain international registration listing and FDA registrations and product listings•Review labeling, promotional material and proposed product changes against regulatory standards•Interact directly with FDA on recalls/corrections and removals as well as MDR reporting•Implement policies and procedures as well as training to comply with 21 CFR 820 and ISO 13485•Supervise and approve the following quality system functions- Document Control (ECO), Complaint Handling, CAPA system, Training system, NCMR, QA activities and Calibration/Process Validation•Supplier Selection/Approval and perform external audits of critical suppliers•Ensure occurrence of Internal Audits and Computer Software Validation

• Provide guidance to project teams to implement Clinical CAPAs on active studies• Create study specific transition plans from existing SOPs to new Global SOPs• Manage project timelines and due dates for the transition plans• Partner with project teams to build quality into processes using new Global SOPs and regulations

•Prepared 510(k) submissions and maintain letters to file for submission changes•Interface with R&D of parent company for testing and US submission requirements•Designated Management’s Representative, conducting and documenting periodic Management Reviews•Implement policies and procedures as well as training to comply with 21 CFR 820 and ISO 13485•Supervise the following quality system functions- Document Control, Complaint Handling, CAPA system, Training system, Supplier Selection/Approval, NCMR, QC activities and Calibration/Process Validation•Perform external audits of critical suppliers, internal audits and Computer Software Validation•Perform MDR reporting and recalls/corrections and removals•Fill the role of Compliance Officer, establish and maintain a compliance program for Physician Consultants•Evaluate and select clinical investigators and sites to meet project specific and regulatory requirements•Responsible for planning, hiring, training and supervision of contractors to support Clinical Affairs

•Design, review and approve labeling, packaging, distribution of clinical trail material for double blind and open label clinical trials in India, United States and Europe•Manage drug supply, distribution and randomized kit verification for clinical trials in Prism EDC system•Manage drug supply and distribution using packaging/labeling contractor custom validated software•Resolve complaints from clinical trial sites, central pharmacies and contractors•Advise QA Specialist’s, QC, and Manufacturing on product quality and safety issues and CAPA•On-site QA representative for aseptic fills and QA representative for project teams•Manage cross functional project team for new fill/finish site•Lead auditor for external contractors•Interact with the manufacturing director, QC manager, inventory control, and purchasing to ensure no interruption in supply of clinical trial materials