Sylvia Barela Lemke
Director, Global Regulatory Affairs, Product Support and Lifecycle Maintenance
Sylvia Barela Lemke is a eficient professional, who works in Alcon, A Novartis Company main office of which is in 730. as a Director, Global Regulatory Affairs, Product Support and Lifecycle Maintenance since 2015. This person has earned professional experience in more than 13 positions at various companies. Sylvia Barela Lemke went to the University of Phoenix and got education there from 2001 to 2005. Mount Vernon, Washington is the city, where the professional was lastly known to be living. This person's e-mail and phone can be easily accessed through SoftwareOfficial by request.
Name variants:
Silvia Lemke,
Sylvie Lemke,
Sylvee Lemke,
Sylveeah Lemke,
Syl Lemke,
Silvie Lemke
Last updated Jun 19, 2024
Contact Information
Last Update
Jul 11, 2022
Email
sy**@gmail.com
Location
Mount Vernon, WA
Company
Workplace
Director, Global Regulatory Affairs, Product Support and Lifecycle Maintenance
Fort Worth, TX
Industry
Pharmaceuticals
Colleagues
Work History
Director, Global Regulatory Affairs, Product Support and Lifecycle Maintenance
6201 South Fwy, Fort Worth, TX 76104
from Nov 16, 2015
Principal Regulatory Affairs Specialist
11811 Willows Rd northeast, Redmond, WA 98052
Principal Regulatory Affairs Specialist
Apr 1, 2013 — Nov 2015
Regulatory Submissions Manager
Ontario, CA
Manage all aspects of Regulatory Affairs: Prepare PMA applications for U.S. approvals
Class IIb Technical Files and Class III Design Dossiers for CE marking per MDD 93/42/EEC
regulatory s...
Aug 2011 — Mar 2013
Regulatory Affairs
Independent regulatory consultant supporting ClinReg Consulting Services, Inc. on various regulatory projects.
Feb 2011 — Aug 2011
Manager, Regulatory Affairs
400 Somerset Corporate Blvd, Bridgewater, NJ 08807
Laid off from company due to position relocation.
Apr 2007 — Dec 2010
Senior Regulatory Affairs Specialist and Interim Regulatory Affairs Manager
1911 Walker Ave, Monrovia, CA 91016
Jan 2005 — Apr 2007
Regulatory Affairs Associate
100 Boston Scientific Way, Marlborough, MA 01752
Organize submission activities for a variety of device regulatory approvals including: U.S. Pre-Market Approvals (PMA), 510(k) and international design dossiers, post-approval reports, expo...
Jan 2004 — Jan 2005
Regulatory Affairs Specialist
345 east Main St #p/o box 708, Warsaw, IN 46580
Sep 2002 — Jan 2004
Regulatory Affairs Specialist
400 Somerset Corporate Blvd, Bridgewater, NJ 08807
Assist in preparation of IDE, PMA and 510(k) submissions to FDA.
Preparation of 510(k) "No File" assessments for changes to existing products.
Prepare and submit IDE and PMA annual progre...
Mar 2001 — Sep 2002
Regulatory Affairs Administrator
400 Somerset Corporate Blvd, Bridgewater, NJ 08807
Solely managed the international registrations for Latin America, Asia Pacific, Canada, and
Europe for all surgical and refractive products. Developed and implemented a standardized
forma...
Mar 2000 — Mar 2001
Regulatory Affairs Coordinator
400 Somerset Corporate Blvd, Bridgewater, NJ 08807
Mar 1998 — Mar 2000
Education
2001 — 2005
Occupations
Executive
Director
Operations Manager
Skills
Pma
Iso 13485
Design Control
Regulatory Affairs
Capa
Medical Devices
Regulatory Submissions
Gmp
21 Cfr Part 11
Quality System
Fda
Validation
Sop
Iso
Ce Marking
Product Development
Iso 14971
V&V
U.s. Food and Drug Administration
Clinical Trials
Quality Auditing
Corrective and Preventive Action
FAQs about Sylvia Barela Lemke
What's the main profession of Sylvia Barela Lemke?
This professional's job is Director, Global Regulatory Affairs, Product Support and Lifecycle Maintenance
What jobs is Sylvia a professional at?
Sylvia is a professional Executive and Director jobs.
Where does Sylvia Barela Lemke live?
Mount Vernon, Washington is the place where Sylvia Barela Lemke currently lives
What is Sylvia Barela Lemke's email?
The professional's email is sy**@gmail.com.
How many companies did Sylvia Barela Lemke work at?
Sylvia Barela Lemke worked at 13 jobs.
What education does Sylvia Barela Lemke have?
Sylvia studied at the University of Phoenix from 2001 to 2005.
What is the industry that Sylvia Barela Lemke is connected to?
This professional works in Medical Devices industry.
What are professional skills of Sylvia Barela Lemke?
This professional has skills in the following areas: Pma, Iso 13485, Design Control, Regulatory Affairs, Capa, Medical Devices, Regulatory Submissions, Gmp, 21 Cfr Part 11, Quality System, Fda, Validation, Sop, and Iso.