Willis Edwards, Rac (Us) Email & Phone Number

Geneva, Switzerland, Ch

Abbott Park, Illinois, Us

• EU MDR Remediation – Regulation (EU) 2017/745• Write/draft the various sections of the EU MDR Summary Technical Documentation (STED) for Class III Medical Devices – Cardiovascular- Seguin Annuloplasty Ring (SARP) and Accessories- Tailor Annuloplasty Ring (TARP) and Tailor Annuloplasty Band (TAB) and Accessories- Rigid Saddle Annuloplasty Ring (RSAR) and Accessories• Pre-Market Approval (PMA) Annual Reports• Draft/compose PMA Annual Report- Trifecta Valve & Trifecta Valve with Glide Technology (Trifecta GT) – April 2022 and April 2023

Kalamazoo, Mi, Us

• Technical Documentation File (TDF) update/remediation for compliance to Regulation (EU) 2017/745 – EU MDR• Cross-functional collaboration to obtain deliverables for completion of Tech File remediation and other regulatory tasks/projects

Baldwin, New York, Us

• Managed the development and implementation of key global regulatory strategies to ensure business objectives are in compliance with local and global Health Authority (HA) regulatory requirements• Reviewed new or proposed legislation and suggested/developed a regulatory strategy to ensure compliance accordingly • Provided guidance for the registration/submission and review process by checking for accuracy, technical consistency, completeness, and compliance of the respective dossier in reference to local and global regulations • Responsible for mentoring associates/specialists as appropriateAccomplishments:• Developed and implemented the Cross-Functional process at Elliquence, LLC; wherein, process ownership was formally defined along with expected tasks/deliverables• Revamped the product (medical device) portfolio’s technical documentation• Suggested and subsequently appointed to lead efforts to identify and recommend a suitable eQMS (electronic Quality Management Software) platform/system that will allow for Elliquence, LLC to fully integrate its processes (cross-functional [interdepartmental] document review and approval)

Warsaw, Indiana, Us

• Supported product transition to EU MDR (European Union Medical Device Regulation) compliance• Provided recommendations/advice for the completion of technical documentation and corresponding GSPR in accordance to Regulation (EU) 2017/745

Farmingdale, New York, Us

• Prepared worldwide regulatory submissions/registrationsProject(s):• Created/developed a system to enhance monitoring of product registrations (spreadsheet)• China Product Registration (National Medical Products Administration [NMPA]) - BoneScalpel Applied Parts/AccessoriesAccomplishment:Successful incorporation of an alert/notification feature for upcoming product (medical device) expiry and associated deadlines within the company’s (Misonix) medical device registration spreadsheet.

Gothenburg, Se

• Prepared worldwide (international) regulatory submissions/registrationsSubmission (Registration) Experience: • Health Canada Class IV License Amendment Application (STED-based Class IV Premarket Medical Device License Application) - C-QUR Coated Mesh Product Family (Bio-surgery) - Flixene ePTFE Vascular Graft • Brazil (ANVISA [Brazilian Health Regulatory Agency])- Chest Drain Accessories- Pneumostat Chest Drain• India Registration Application (Submission)- Advanta V12 Stent (Endovascular)• Ukraine Registration - Atrium Portfolio (Vascular Grafts, Thoracic Drains, Surgical Mesh, Endovascular Stent)• Taiwan Registration/Submission- Flixene Vascular Graft• Egypt Registration/Submission - Chest DrainsTechnical File Remediation/Update:European Union (EU) Technical File (Tech File) and Corresponding Essential Requirements Checklist (ERC)/Essential Principles (EP) Checklist Update/Remediation

Minneapolis, Mn, Us

• Regulatory Affairs input (guidance) provided to cross-functional teams tasked with maintenance of business projects as well as ascertaining global impact by completing regulatory assessment reports• Reviewed marketing literature for compliance with regulations governing advertising and promotion• Collaborated with internal Medtronic departments to obtain and understand registration requirements • Reviewed product labeling for compliance with global labeling regulations

Bad Homburg, Frankfurt, De

• Processed MDR/ADE decision trees and is able to complete MDR submissions• Understands the Field Alert Reporting (FAR) process and evaluate, distinguish and recommend complaints for FAR reporting• Provided coding support and reviewed / updated complaints in the Complaint Management Database

Raynham, Ma, Us

• Responsible for the oversight and direct support of technical evaluations and investigations and investigational tasks required for complaint processing/closure.• Communicate with Quality Engineers, Manufacturing, Product Development and other functional experts as needed to ensure clear understanding/investigation of applicable issues.• Electronic Medical Device Reporting (eMDR) submissions (Initial and follow-up reports)..Accomplishment: • Requested to join the Closure Team within four months of hire. This peer review role involves the review and approval of submitted complaints for final closure.

Cork, Ireland, Ie

• Audit JCI and subcontractor operations and documentation to ensure compliance with Customer identified regulatory requirements. JCI policies/procedures and contractual requirements• Interfaced with regulatory compliance personnel and JCI operations to identify applicable regulatory and compliance requirements to ensure accurate understanding of those requirementsAccomplishments: • Led a Root Cause Investigation/Root Cause Analysis in response to a directive given by the customer (Bristol-Myers Squibb)• Created/developed the JCI Internal Audit Schedule (Bristol-Myers Squibb account) that was used for the 2011 and 2012 audit cycles

• Conducted research on assigned issues that contributed to the attainment of a defined objectiveAccomplishments: • Direct involvement in facilitating the implementation of suggested/needed changes to the Change Management Governance SOP (LIMS Table)• Played a key role in developing templates (LIMS Change Request forms) for the Environmental Monitoring department

Graduate Certificate (Graduate Level), Regulatory Affairs

Master Of Science, Biotechnology: Biotechnology Management

Bachelor Of Science, Biological Science