James Shene Email and Phone Number
Marlborough
James Shene's Location
Leander, Texas, United States, United States
James Shene's Contact Details
James Shene work email
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James Shene personal email
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James Shene phone numbers
About James Shene
James Shene is a Principal Regulatory Affairs Specialist at Boston Scientific. He possess expertise in capa, medical devices, quality system, iso 13485, fda and 16 more skills.
James Shene's Current Company Details
Boston Scientific
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Principal Regulatory Affairs Specialist
Marlborough
- Website:
- bostonscientific.com
- Employees:
- 10
- Company phone:
- +1 800-876-9960
- Company email:
- info@bostonscientific.com
James Shene Work Experience Details
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Principal Regulatory Affairs SpecialistBoston Scientific Dec 2023 - PresentMarlborough, Ma, Us
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Senior Regulatory Affairs SpecialistApollo Endosurgery Oct 2022 - Dec 2023Austin, Tx, Us -
Regulatory Affairs ManagerArtivion, Inc. Jan 2022 - Oct 2022Kennesaw, Ga, Us -
Regulatory Affairs ManagerArtivion, Inc. Oct 2021 - Oct 2022Kennesaw, Ga, Us
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Senior Regulatory Affairs SpecialistArtivion, Inc. Dec 2020 - Oct 2021Kennesaw, Ga, Us
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Senior Regulatory Affairs SpecialistApollo Endosurgery Aug 2019 - Dec 2020Austin, Tx, Us
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Regulatory Affairs Program ManagerLivanova Mar 2018 - Dec 2020London, GbIn addition to my responsibilities as a Senior Regulatory Affairs Specialist, I was responsible for the following:o Designated as the primary regulatory affairs contact for all VNS Therapy regulatory submissions (Epilepsy and Depression Indication) for the US, EU, and Canada.o Supervised the coordination of all RA deliverables and oversaw the preparation of individual regulatory submissions.o Directed preparation activities to support the recertification of VNS Therapy products under the European Union (EU) Medical Device Regulation (MDR) involving Class III, Class IIa and Class I products.o Engaged and negotiated with various regulatory bodies regarding the review and approval of new products and product changes.o Developed and reviewed global regulatory submission strategies for new products and incremental product changes.o Presented the status of regulatory initiatives, deliverables (e.g. submissions, approvals, international product registration, EU MDR Certification progress) and surveillance activities to the LivaNova executive leadership team via Project Review Board (PRB) Meetings and Quarterly Management Review.During a leadership transition involving the franchise RA director role, I was given the responsibility for the following tasks: • Designated as the primary regulatory affairs contact for all VNS Therapy (Epilepsy and Depression Indication) regulatory submissions (domestic and international) at the franchise level.• Managed a group of four (4) employees (three (3) regulatory specialists and one (1) administrative assistant). This included, but was not limited to, administering weekly one on one sessions with each employee, coordinating deliverable responsibilities, creating and relaying the outcome of employee performance reviews.• Created and adhered to annual department budgets and submission schedules. -
Senior Regulatory Affairs SpecialistLivanova Mar 2016 - Dec 2020London, GbNew Product Development Efforts: Participated in the development of new Class III Medical Devices (Neuromodulation products)• Design Input: Provided design input (e.g. suggestions for risk controls, design considerations, etc.) during the early stages of product development in an effort to reduce regulatory risks and time to market. • Regulatory Strategy Development: Developed and maintained global regulatory strategizes for new and modified products. • Pre-Submission Regulatory Interactions: Led a cross-functional product development team through the preparation and presentation of materials needed to support pre-submission interactions with regulatory bodies• Clinical Trial Support: Supported a US based clinical trial (Class III Medical Device) through the submission of an IDE and supporting supplements• Technical Reviews: Reviewed and approved development documentation as part of a technical review board.• Regulatory Submissions (FDA/Notified Body): Prepared and submitted various regulatory applications for the approval of new products and design changesPost-Approval Support: maintained the regulatory compliance of approved Class III/AIMDD products through the following activities:• Change Control/Technical Reviews: Reviewed changes to quality system documentation, product design specifications and manufacturing documentation and assessed their regulatory impact.• Post-Approval Regulatory Submissions: Prepared and submitted various regulatory applications supporting changes to manufacturing, product design, and product labeling• New Manufacturing Facility Support: Supported the implementation of a new Costa Rican manufacturing facility through applicable submissions• International Product Registration Efforts: Successfully initiated and maintained product registration efforts in the Middle East and Eastern Europe.• Supplier Change Assessments: Reviewed and determined the regulatory reportability of supplier change requests.
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Regulatory Specialist IiLivanova Aug 2012 - Mar 2016London, Gb•Prepared and submitted various regulatory applications (e.g. IDE supplements, IDE annual reports, Compassionate Use Requests, Emergency Use Notifications, PMA Annual Report, 30-Day Notices, Real Time Reviews, Notices of Change, 180 Day Supplements and Design Dossiers).•Participated in cross-functional design teams as a regulatory representative.•Reviewed changes to Quality System documentation as part of a Technical Review Board (TRB) and assessed their regulatory impact.•Represented Regulatory Affairs as part of a Change Review Board (CRB) during the review and disposition of design changes requested during the product development process.•Developed regulatory strategies impacting multiple product lines.•Initiated global product registrations efforts in support of new products and distributors:
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Clinical Quality Engineer IiLivanova Jul 2011 - Aug 2012London, Gb
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Clinical Quality Engineer ILivanova Sep 2009 - Jul 2011London, Gb•Actively monitored the results of Post-Market Surveillance (PMS) investigations for trends which may necessitate additional investigation and/or actions under the Company’s corrective and preventive action (CAPA) process.•Thoroughly reviewed PMS investigations for appropriate regulatory reportability decisions, quality, and completion of required investigation activities.•Performed an internal audit of management review, CAPA, and internal audits.•Provided investigation guidance and assistance with root cause determination to individuals responsible for active PMS investigations.•Contributed to the development of new products through the creation of PMS reports utilized for design inputs in addition to participating in associated validation activities.
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Clinical Engineer ILivanova Jun 2008 - Sep 2009London, Gb•Provided product related clinical/technical support to medical professionals and company employee’s.•Evaluated and assessed incoming customer experience reports in accordance to applicable domestic and foreign regulatory policies. •Proactively investigated product performance issues in an effort to establish a clear and accurate root cause.•Actively participated in cross-functional validation teams assembled to resolve product quality issues.•Completed the AQS management system course “ISO 9001:2008 36 Hour Lead Auditor with Medical Device (ISO 13485) Focus” and obtained an in-depth understanding of the ISO 13485 Audit Process. •Supported company corrective action investigations through the development/execution of product testing and complaint data analysis.
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Microbiology Tech IiArgon Medical Devices Jan 2007 - Jun 2008Plano, Tx, Us•Audited the quality system as a part of an internal audit team and implemented resulting corrective actions.•Developed procedures and protocols (IQ/OQ/PQ) aimed at validating laboratory methods and equipment. •Analyzed and assessed experimental data through statistical analysis and data trending.•Established new product processes as a member of a cross-functional design team.•Monitored and assessed the source contaminant activity, in accordance with company and regulatory policies, throughout the manufacturing process. •Attended the Center for Professional Advancement (CfPA) course “Microbiological Control and Validation” which provided attendee’s with an in-depth understanding of quality system controls and monitoring through regulatory exposure and case studies.
James Shene Skills
Capa
Medical Devices
Quality System
Iso 13485
Fda
Cross Functional Team Leadership
Design Control
Management
Product Development
Root Cause Analysis
Microsoft Office
Iso 14971
Quality Assurance
Biomedical Engineering
Risk Management
21 Cfr
Corrective And Preventive Action
Regulatory Submissions
Regulatory Reporting
Regulatory Requirements
Validation
James Shene Education Details
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Texas A&M UniversityBiomedical Science -
Texas A&M UniversityGeneral
Frequently Asked Questions about James Shene
What company does James Shene work for?
James Shene works for Boston Scientific
What is James Shene's role at the current company?
James Shene's current role is Principal Regulatory Affairs Specialist.
What is James Shene's email address?
James Shene's email address is ja****@****ndo.com
What is James Shene's direct phone number?
James Shene's direct phone number is +197925*****
What schools did James Shene attend?
James Shene attended Texas A&m University, Texas A&m University.
What skills is James Shene known for?
James Shene has skills like Capa, Medical Devices, Quality System, Iso 13485, Fda, Cross Functional Team Leadership, Design Control, Management, Product Development, Root Cause Analysis, Microsoft Office, Iso 14971.
Who are James Shene's colleagues?
James Shene's colleagues are Ashlee Atsuko Fukushi, Carolina Curiel Llamazares, Loïc Jund, Juan Carlos Gaviria, Viviana Artavia, Bill Perusek, Andrew Lee.
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