Pauline Shand
Maricopa,AZ
Summary
Seasoned Regulatory Affairs Professional with 16 years in developing effective processes and executing regulatory affairs initiatives for the Medical Device industry. Improved processes and assisted product development in meeting regulatory requirements. Maintained and followed up on records of regulatory information and submissions.
Overview
16
16
years of professional experience
Work History
Regulatory Affairs Consultant
Medtronic
2023.07 - Current
- Served as a Regulatory Affairs Lead/Project Manager to support (15) product, process, and systems remediation projects to ensure compliance to EU MDR Requirements, FDA, and local regulatory requirements
- Communicated Regulatory Affairs initiatives related to stakeholders (PMO Lead, Supply Chain, Marketing, R&D, Quality, Clinical Affairs, and EU Notified Body)
- Coordinated Technical Documentation and STED Revisions
- Assisted international affiliates with international submissions and additional information requested by notified bodies or component authorities
- Reviewed and approved product labeling, non-promotional, and promotional marketing materials to ensure compliance to FDA, EU MDR requirements, and International regulatory requirements
- Reviewed and approved Engineering Change Notices and Operation Change Notices to ensure compliance to FDA, MDR, and international regulatory requirements
- Interpreted existing and new US/international regulatory requirements.
MDR RA Manager (Regulatory Consultant)
Vyaire Medical, Inc
2021.12 - 2023.05
- Served as a Regulatory Affairs Lead supported (25) product, process, and systems remediation projects to ensure compliance to EU MDR Requirements
- Supported International Regulatory Submissions
- Communicated Regulatory Affairs initiatives related to MDR to stakeholders (PMO Lead, Supply Chain, Marketing, R&D, Quality, Clinical Affairs, and EU Notified Body)
- Coordinated Technical Documentation Submission Deliverables and Timeline
- Evaluated expected impact from EU MDR initiative to New Product Development (NPD) team members
- Assisted international affiliates with international submissions and additional information requested by notified bodies or component authorities
- Reviewed and approved product labeling, non-promotional, and promotional marketing materials to ensure compliance to FDA, EU MDR requirements, and International regulatory requirements
- Reviewed and approved Engineering Change Notices and Operation Change Notices to ensure compliance to US/international regulatory requirements
- Interpreted existing and new US/international regulatory requirements
- Implemented project plans with milestones and deliverables
- Drafted Standard Operating Procedures to ensure compliance to MDR requirements.
Sr. Manager, Regulatory Affairs
Thermo Fisher Scientific
2021.10 - 2022.04
- Managed Regulatory Affairs staff (Senior and Junior level Specialists)
- Served as a Regulatory Affairs Lead to support (10) product, process, and systems remediation projects to ensure compliance to EU IVDR Requirements
- Supported international Regulatory Affairs strategies for international product submissions
- Communicated Regulatory Affairs initiatives and risks to Stakeholders (PMO Lead, Supply Chain, Marketing, R&D, and Quality)
- Acquired and maintained current knowledge of applicable regulatory requirements and scientific/technical issues in a specific region and discipline as relevant to assigned projects
- Reviewed and approved product labeling and promotional marketing materials to ensure compliance with regulatory requirements
- Reviewed and approved Engineering Change Orders.
Global Regulatory Affairs Project Manager (Consultant)
DePuy Synthes and Ethicon, Johnson & Johnson
2016.07 - 2021.10
- Managed Regulatory Affairs continuous improvements projects within a matrix environment
- Delegated, supervised, and tracked Regulatory Affairs team members’ deliverables
- Communicated Regulatory Affairs initiatives and risks to the Steering Team stakeholders (PMO Lead, Supply Chain, Marketing, R&D, and Quality)
- Implemented project plans with milestones and deliverables
- Served as the Regulatory Affairs Lead on cross-functional supplier change project teams
- Acquired and maintained current knowledge of applicable regulatory requirements and scientific/technical issues in a specific region and discipline as relevant to assigned projects
- Reviewed and approved product labeling and promotional marketing materials to ensure compliance with regulatory requirements
- Reviewed and approved Engineering Change Orders
- Co-Authored 510(k) submission
- Coordinated and assisted with international registrations for Latin America, Europe, Middle East, and Asia Pacific.
Regulatory Affairs Manager
Roche Tissue Diagnostics
2015.03 - 2016.07
- Provided support to currently marketed products, e.g., review engineering changes, labeling, promotional material, product changes and documentation for compliance and as pertains to domestic and international regulatory requirements
- Managed submission activities for a variety of device regulatory approvals including the CE mark, US premarket approvals (PMAs), US premarket notifications (510(k)s), IDEs, post-approval reports, annual reports, export certificates, and establishment registrations and device listings
- Managed submission activities for Study Risk Determination, Investigational Device Evaluations (IDE), and Pre-Submissions
- Adhered to departmental budget(s)
- Interfaced with regulatory authorities on regulatory and technical matters
- Managed the creation and review of Standard Operating Procedures and policy guidelines for the Regulatory Affairs department
- Served as Functional Lead on Lifecycle or project team(s).
Senior Manager, Regulatory Affairs
OrthoPediatrics
2014.07 - 2015.03
- Directed and supervised the work of Regulatory Affairs professionals and fostered professional development
- Provided oversight and prioritization of departmental tasks and projects
- Facilitated the implementation of a risk management system compliant to ISO 14971:2012 Annex ZA
- Managed CAPA(s) by implementing execution of a project plan, acquired resources, coordinated weekly meetings, and provided status reports to management
- Interpreted and applied FDA and international regulations to business practices and provided regulatory input, advice, and guidance to the organization
- Managed the development of technical files, STED, and design dossiers for international registrations
- Reviewed and approved product labeling, non-promotional, and promotional marketing materials to ensure compliance to regulatory requirements
- Reviewed and approved Clinical Evaluation Reports.
Associate Project Manager
Zimmer Holdings Inc.
2012.03 - 2014.07
- Served as Regulatory Affairs Lead on new product development cross-functional project teams from initial stage through securing government approvals
- Managed CAPA(s) by implementing execution of project plans, acquired resources, coordinated weekly meetings, and provided status reports to management
- Authored, submitted, and cleared Traditional 510(k)s
- Authored, submitted, and cleared change notices for Class III medical devices for EU and answered deficiency inquiries within specified deadline
- Drafted technical files for Class I, Class Im (measuring function), Class Is (sterile), Class IIa, and Class IIb EU/Australia medical devices
- Drafted domestic letters-to-file
- Applied for CE Mark recertification with European notified body (BSI)
- Reviewed and approved product labeling, non-promotional and promotional marketing materials to ensure compliance to regulatory requirements
- Reviewed and approved Engineering Change Notices and Operation Change Notices to ensure compliance to US/international regulatory requirements
- Mentored and trained new Regulatory Affairs staff members
- Maintained STED files for international registrations
- Reviewed and approved Clinical Evaluation Reports.
Regulatory Affairs Specialist
BIOMET 3i
2011.03 - 2012.03
- Served as the Regulatory Affairs Lead on new product development cross-functional project teams from initial stages through securing government approvals in the US and international markets
- Authored 510(k), Letters to File (LTF), and international regulatory submissions
- Drafted technical files for Class I, Class IIa, and Class IIb EU/Australia medical devices
- Reviewed and approved product labeling, non-promotional and promotional marketing materials to ensure compliance to US and International regulatory requirements
- Reviewed and approved Document Change Requests to ensure compliance to US and international regulatory requirements
- Interpreted existing and new US/international regulatory requirements
- Participated in European notified body audit (BSI)
- Managed and tracked international submissions.
International Regulatory Affairs Group Leader
Nipro Diagnostics, Inc.
2010.09 - 2011.03
- Authored and submitted international regulatory submissions for Australia and Hong Kong
- Drafted, reviewed, and approved Class IIb EU/Australia Technical Files
- Authored a cleaning and disinfecting protocol for blood glucose meters
- Authored a license to export submission
- Reviewed and approved product labeling, non-promotional and promotional marketing materials to ensure compliance to US/International regulatory requirements.
- Trained new team members by relaying information on company procedures and safety requirements.
Regulatory Affairs Associate
Stryker
2008.07 - 2010.09
- Authored, submitted, and cleared 510(k)s and international regulatory submissions and drafted domestic letters-to-file
- Authored, submitted, and cleared design dossiers for Class III medical devices for the EU and answered deficiency inquiries within a specified deadline
- Served as the Regulatory Affairs Lead on new product development cross-functional project teams from initial stages through securing government approvals in the US and international markets
- Drafted and reviewed responses to additional information requests in collaboration with a cross-functional project team
- Applied for CE Mark recertification with the European notified body (BSI)
- Drafted technical files for Class I, Class Im (measuring function), Class Is (sterile), Class IIa, and Class IIb EU/Australia medical devices
- Reviewed and approved product labeling, non-promotional and promotional marketing materials to ensure compliance to US/International regulatory requirements
- Reviewed and approved biomechanical reviews, clinical studies, and journal articles to ensure compliance to US and international regulatory requirements
- Reviewed and approved Engineering Change Notices and Operation Change Notices to ensure compliance to US/international regulatory requirements
- Interpreted existing and new US/international regulatory requirements.
Education
Master of Science in Jurisprudence (MSJ) - Medical Device, Pharmaceutical, and Compliance Law
Seton Hall University School of Law
Newark, NJ05.2018
Bachelor of Science - Human Development
Binghamton University
Binghamton, NY05.2000
Skills
- Document Control
- Product Lifecycle Management
- FDA regulations
- Change Control Management
- Regulatory Submissions
- Labeling Compliance
- Medical Device Regulations
- Project Management
- Technical Documentation
- Impact Assessment
- International Regulations
- Stakeholder Communication
- Teamwork and Collaboration
Timeline
Regulatory Affairs Consultant
Medtronic
2023.07 - Current
MDR RA Manager (Regulatory Consultant)
Vyaire Medical, Inc
2021.12 - 2023.05
Sr. Manager, Regulatory Affairs
Thermo Fisher Scientific
2021.10 - 2022.04
Global Regulatory Affairs Project Manager (Consultant)
DePuy Synthes and Ethicon, Johnson & Johnson
2016.07 - 2021.10
Regulatory Affairs Manager
Roche Tissue Diagnostics
2015.03 - 2016.07
Senior Manager, Regulatory Affairs
OrthoPediatrics
2014.07 - 2015.03
Associate Project Manager
Zimmer Holdings Inc.
2012.03 - 2014.07
Regulatory Affairs Specialist
BIOMET 3i
2011.03 - 2012.03
International Regulatory Affairs Group Leader
Nipro Diagnostics, Inc.
2010.09 - 2011.03
Regulatory Affairs Associate
Stryker
2008.07 - 2010.09
Master of Science in Jurisprudence (MSJ) - Medical Device, Pharmaceutical, and Compliance Law
Seton Hall University School of Law
Bachelor of Science - Human Development
Binghamton University
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