Mark Puopolo is a eficient professional, that works in Thermo Fisher Scientific main office of which is in 625. as a Senior Manager, Regulatory Affairs from 2019. Mark Puopolo gained professional experience in more than 12 positions at different companies. Mark Puopolo went to the Worcester Polytechnic Institute and was studying from 2007 to 2007. Mark Puopolo has the following professional qualifications: Iso 19011:2011 Management System Auditor, Iso 13485:2016 Lead Auditor, and Iso 13485:2003 Lead Auditor. Woburn, Massachusetts is the city, where the professional was known to live. The professional's e-mail and phone can be accessed through Connexy by request.
Name variants:
Marc Puopolo,
Marcus Puopolo,
Markus Puopolo,
Marquis Puopolo,
Mark Puopolo
Contact Information
Last Update
Jul 12, 2022
Email
ma**@rcn.com
Location
Woburn, MA
Company
Thermo Fisher Scientific
Workplace
Senior Manager, Regulatory Affairs
Work History
Senior Manager, Regulatory Affairs
168 3Rd Ave, Waltham, MA 02451
Responsible for advising Chromatography and Mass Spectrometry Division (CMD) Leadership and Clinical Marketing teams regarding medical device compliance strategies, supporting RA-related new...
from Jun 2019
Head of Quality Assurance and Regulatory Affairs
260 H Fordham Rd, Wilmington, MA
Overall responsibility for Quality Assurance and Regulatory Affairs Compliance for Medical Products manufactured and/or distributed from the Wilmington MA Site. Primary responsibilities incl...
2017 — Mar 2019
Director of Quality Assurance and Regulatory Affairs and Management Representative
400 Tradecenter, Woburn, MA 01801
Overall responsibility for Quality Assurance and Regulatory Affairs Compliance for IVD Products manufactured and/or distributed from the Woburn MA Site. Primary responsibilities include QMS ...
Apr 2016 — Oct 2017
Associate Director, Regulatory Affairs and Head of Ra
1 Wall St, Burlington, MA 01803
Responsible for Regulatory Affairs Compliance for IVD Products manufactured and/or distributed from Exton, PA, San Diego, CA,, Stamford, CT and Prince Edward Island, Canada. Primary responsi...
Apr 2014 — Apr 2016
Senior Manager, Regulatory Affairs
Manage RA group and support of World-Wide Regulatory Compliance of Medical Devices and Commercial Devices, creation and updates to Technical Files and Dossiers for EU Submissions (CE Mark), ...
Aug 2011 — Apr 2014
Senior Regulatory Affairs Specialist
710 Medtronic Pkwy, Minneapolis, MN 55432
Jan 2005 — May 2007
Regulatory Affairs and Quality Control Manager
401 Carlson Pkwy, Minnetonka, MN 55305
Sep 1996 — Sep 2000
Education
2007 — 2007
2006 — 2006
2005 — 2005
1997 — 1999
1988 — 1992
1983 — 1987
Occupations
Executive
Senior Manager
IT Professional
Software Tester
Operations Manager
Computer Specialist
Skills
Fda
Medical Devices
Design Control
Capa
Quality System
Regulatory Affairs
Iso 13485
Quality Assurance
Ce Marking
Regulatory Requirements
Iso 14971
Validation
Quality Control
Quality Management
Product Development
Medical Device Directive
Gmp
Biotechnology
Biomedical Engineering
V&V
Quality Auditing
Pma
Gxp
Computer System Validation
Iso
21 Cfr Part 11
Process Improvement
Change Control
Corrective and Preventive Action
U.s. Food and Drug Administration
Regulatory Submissions
21 Cfr
R&D
Glp
Software Documentation
Iec 60601
Iec 62304
Ide
Sop
Regulations
Ind
Technical Files
Good Laboratory Practice
Iso Standards
Verification and Validation
Fda Gmp
Regulatory Strategy Development
Pre Ide
FAQs about Mark Puopolo
What's the profession of Mark Puopolo?
This professional's job is Senior Manager, Regulatory Affairs
What jobs is Mark Puopolo a professional at?
Mark Puopolo is proficient at Executive and Senior Manager jobs.
Where is Mark Puopolo currently located?
The expert is currently located in Woburn, Massachusetts.
Does Mark Puopolo have the email address?
ma**@rcn.com is The expert's email address.
How many companies did Mark Puopolo work at?
Mark Puopolo worked at 12 jobs.
Where has Mark Puopolo studied?
Mark studied at the Worcester Polytechnic Institute from 2007 to 2007.
Are there any professional certifications Mark Puopolo has?
The professional received the following certifications: Iso 19011:2011 Management System Auditor, Iso 13485:2016 Lead Auditor, and Iso 13485:2003 Lead Auditor.
What is the industry that Mark Puopolo worked in?
Mark Puopolo works in Medical Devices industry.