Name variants:
Paula Shand
Last updated Jun 12, 2024
Contact Information
Workplace
Colleagues
Work History
Senior Manager Regulatory Affairs
2850 Frontier Dr, Warsaw, IN 46582
Jul 2014 — Mar 2015
Regulatory Affairs Manager
1910 east Innovation Park Dr, Tucson, AZ 85755
Ventana Medical Systems, Inc., a member of the Roche Group, innovates and manufactures instruments and reagents that automate tissue processing and slide staining for cancer diagnostics. VEN...
from Mar 2015
Associate Project Manager, Regulatory Affairs
345 east Main St #p/o box 708, Warsaw, IN 46580
Oct 2013 — Jul 2014
Senior Specialist, Regulatory Affairs
345 east Main St #p/o box 708, Warsaw, IN 46580
Serve as a RA designee on new product development cross-functional teams
Managed a CAPA by developing and executing a project plan, Authored, submitted, and cleared 510(k)s
Authored, subm...
Mar 2012 — Nov 2013
Regulatory Affairs Specialist
4555 Riverside Dr, Palm Beach Gardens, FL 33410
Served as the RA designee on new product development cross-functional team
Authored and submitted 510(k)s and international registrations
Drafted letters-to-file
Reviewed and approved pr...
Mar 2011 — Mar 2012
International Regulatory Affairs Specialist Ii Group Leader
Authored and submitted international regulatory submissions for Hong Kong and Australia
Drafted, reviewed, and approved Class IIb CE-Marking technical files
Authored a license to export s...
Sep 2010 — Mar 2011
Regulatory Affairs Associate
2825 Airview Blvd, Kalamazoo, MI 49002
Authored, submitted, and cleared 510(k)s and international regulatory submissions
Served as the RA designee on new product development cross-functional teams
Drafted and reviewed communic...
Jul 2008 — Sep 2010
Paralegal
151 north Main St SUITE 202, New City, NY 10956
Supervised and delegated assignments to legal staff
Recruited, hired, and trained new staff members
Drafted, reviewed, and negotiated provisions of Contract of Sale
Drafted and filed ban...
Jul 2002 — Oct 2007
Education
2015 — 2017
2000 — 2001
1996 — 2000
Occupations
Executive
Manager
Senior Manager
Operations Manager
Skills
Medical Devices
Fda
Regulatory Affairs
Capa
Iso 13485
Design Control
Regulatory Submissions
Quality System
Product Development
Iso 14971
Ce Marking
Cross Functional Team Leadership
V&V
Biomedical Engineering
Biotechnology
Orthopedics
Orthopedic
21 Cfr
Fda Gmp
Medical Device Directive
Technical Files
U.s. Food and Drug Administration
FAQs about Pauline Shand
What is the main profession of Pauline Shand?
The expert is a Regulatory Affairs Manager.
What jobs is Pauline proficient at at?
Pauline is proficient at such jobs as Executive and Manager.
Where is Pauline Shand currently located?
The expert is currently located in Chandler, Arizona.
What is Pauline's email?
Pauline's email is pa**@hotmail.com.
How many companies did Pauline Shand work at?
Pauline Shand worked at eight jobs.
Where has Pauline Shand studied?
Pauline studied at the Seton Hall University School of Law from 2015 to 2017.
Are there any industries Pauline Shand is connected to?
This professional works in Medical Devices industry.
Are there any special skills, that Pauline Shand has?
This person has the following skills: Medical Devices, Fda, Regulatory Affairs, Capa, Iso 13485, Design Control, Regulatory Submissions, Quality System, Product Development, Iso 14971, and Ce Marking.