Tajudeen Oladele Email and Phone Number
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Quality and Regulatory compliance engineering professional engaged in medical device/combination products technical consulting.Hands-on responsibility in planning, developing and the execution of product and process road-map for medical device organizations. Coordinating and communicating across functions in multiple US and international sites. Navigating project teams in realization of key deliverables aligned with business objectives and priorities.
Kes
View- Website:
- kespackaging.com
- Employees:
- 296
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KesFairfield, Ca, Us
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Senior Quality & Regulatory Compliance Engineering Professional At KesKes Aug 2008 - PresentProduct/Process Quality Assurance, Domestic and International Regulatory Submissions, Internal audit, Product Research and Development, Computerized System Validation, and Products regulatory Approvals to IEC/ISO Technical Standards.
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Csa/Ul/Iec 60601 Senior Principal ConsultantKes Jul 2010 - Feb 2011Global Regulatory Compliance Engineering Consultant at Cardiac Science.
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Product Safety And Regulatory Compliance ConsultantMaetrics Jul 2009 - PresentMonroeville, Pa, UsIndependent Senior Quality and Regulatory engineering professional engaged in medical device/combination products technical consulting, hands-on responsibility in planning, developing and the execution of product and process roadmap for medical device organizations. Coordinating and communicating across functions in multiple US and international sites. Navigating project teams in realization of key deliverables aligned with business objectives and priorities. -
Project Manager, Regulatory AffairsJohnson & Johnson Surgical Vision Oct 2017 - Oct 2018Served as the Conduit between regulatory agencies and Johnson & Johnson Surgical vision, reviews current IEC/EN 60601-1, 60601-1-2, IEC62304, IEC62366, IEC61010, IEC 60529, IEC60825 and IEC62471 regulatory compliance requirements and provides consult to design and development, assesses product changes against FDA and notification requirements for external notified bodies. Responsible for Countries registration/re-certifications that includes China, Brazil, EU product re-evaluation at tests Laboratories. Regulatory Affairs representative on new and sustaining engineering product technical changes. Leadership roles in review and approval of technical reports, responsible for FDA annual report package development and related follow up regulatory activities.
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Senior Technical ConsultantNeozene, Inc. May 2016 - Sep 2017Oakland, Ca, UsServed as the Conduit between regulatory agencies and Companies on 93/42/EEC, 90/385 and 98/79 Device fillings and approvals. IEC/EN 60601-1, 60601-1-2, IEC62304, IEC62366, IEC61010, IEC 60529, IEC60825 and IEC62471 regulatory compliance and providing consult to design and development, product changes FDA in compliance with FDA, Notified Body and other Countries Regulatory Agency . Responsible for Countries registration/re-certifications that includes China, Brazil, EU product re-evaluation at tests Laboratories. Regulatory Affairs representative on new and sustaining engineering product technical changes. Leadership roles in review and approval of technical reports, responsible for FDA annual report post market surveillance activities. -
Automation Engineering - Validation ConsultantIntarcia Therapeutics, Inc. 2016 - 2016Boston, Ma, Us -
Automation Engineering - Validation ConsultantIntarcia Therapeutics, Inc. 2016 - 2016Boston, Ma, Us
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Automation Engineering - Validation ConsultantIntarcia Therapeutics, Inc. 2016 - 2016Boston, Ma, Us
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Compliance Engineering - Independent ConsultantNew Star Lasers 2014 - 2014Regulatory Approvals, Quality Assurance, Product Research and Development.
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Compliance Engineering ConsultantNew Star Lasers 2014 - 2014
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Compliance Engineering ConsultantNew Star Lasers 2014 - 2014Quality and Regulatory Compliance Engineering - Independent Consultant
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Regulatory SpecialistVarian Medical Systems 2014 - 2014Palo Alto, Ca, UsQuality Assurance, Domestic/International Regulatory Submissions, Product Research and Development. -
Regulatory SpecialistVarian Medical Systems 2014 - 2014Palo Alto, Ca, Us
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Senior Regulatory Affairs And Quality System Manager - Independent ConsultantOptovue Oct 2012 - Oct 2013Lombard, Il, UsRegulatory Affairs and Quality Assurance -
Engineering Chief - Independent ConsultantTerumo Cardiovascular Systems Feb 2011 - Jun 2012Ann Arbor, Michigan, UsGlobal Safety Compliance and Regulatory Affairs -
Compliance Engineer/Medical Device Quality System Auditor - Independent ConsultantTuv Sud Jul 2008 - Jul 2010IEC/UL 60601 Compliance Engineer /Product technical evaluation, Computerized Systems Validation. ISO 9001, ISO 13485:2003, 93/42/EEC with 2007/47/EC Quality System Auditor.
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Qa Compliance/ Project ManagerArena Pharmaceuticals Jun 2007 - Jul 2008San Diego, Ca, UsRegulatory Affairs, Computerized Systems Validation, Quality Assurance, Project Management. -
Validation Engineer - Contractor -Full TimeIntel Corporation Oct 2005 - Jul 2006Santa Clara, California, UsLead Engineer responsible for the Validation of Intel Optical Networking Systems. -
EngineerRight Management Jan 2005 - Mar 2005Milwaukee, Wi, UsQuality and Regulatory affairs training. -
Compliance/Hardware Diagnostic Engineer - Full TimeAlcatel Jun 1999 - Jan 2005Espoo, Southern Finland, FiRegulatory Affairs, Computerized Systems Validation, Quality Assurance, Project Management. -
Compliance Engineering Manager - Full TimeEmc Technologies Aug 1997 - May 1999International and Domenstic regulatory product submissions, Compliance Engineering, project management.
Tajudeen Oladele Skills
Tajudeen Oladele Education Details
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University Phoenix, ArizonaTechnology Management -
San José State UniversityElectrical/Electronic Engineering
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The Polytechnic, IbadanPhysics & Electronic Engineering
Frequently Asked Questions about Tajudeen Oladele
What company does Tajudeen Oladele work for?
Tajudeen Oladele works for Kes
What is Tajudeen Oladele's role at the current company?
Tajudeen Oladele's current role is Quality/Regulatory Compliance Professional; Domestic/International regulatory filings and post market Surveillance..
What is Tajudeen Oladele's email address?
Tajudeen Oladele's email address is to****@****bal.net
What is Tajudeen Oladele's direct phone number?
Tajudeen Oladele's direct phone number is (510) 746*****
What schools did Tajudeen Oladele attend?
Tajudeen Oladele attended University Phoenix, Arizona, San José State University, The Polytechnic, Ibadan.
What are some of Tajudeen Oladele's interests?
Tajudeen Oladele has interest in Children, Product Development, Regulatory, Environment, Agency Certifications, Education, Compliance Testing, Science And Technology, Health, Quality System Management.
What skills is Tajudeen Oladele known for?
Tajudeen Oladele has skills like Quality System, Quality Assurance, Fda, Medical Devices, Regulatory Affairs, Cross Functional Team Leadership, Testing, Project Management, R&d, Iso 14971, Quality Auditing, Product Development.
Who are Tajudeen Oladele's colleagues?
Tajudeen Oladele's colleagues are Suresh Naban, Filip Zdobinsky, Marcus Hill, Dave Maycock, Dan Metz, Syed Muhammad Imran, Jessie Agustin.
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