Jackie McCulloch has been a Regulatory Affairs Associate in Alku since 2019. Additionally, this person has professional experience at more than 13 companies in the related field. Jackie has a total work experience of 29+ years. Jackie studied at the Purdue University from 1984 to 1987. This person received the following certifications: Rac, Rabaqs Certified Iso 13485 Lead Auditor, and Medical Writer. Washington, DC is the place where Jackie McCulloch currently lives. You can find this professional's current phone number and email with our search.
Name variants:
Jack Mcculloch,
Jackson Mcculloch,
John Mcculloch,
Jacqueline Mcculloch
Contact Information
Last Update
Feb 1, 2016
Email
ja**@sbcglobal.net, ja**@thermofisher.com
Location
Washington, DC
Company
Workplace
Regulatory Affairs Associate
Andover, MA
Industry
Staffing and Recruiting, Investment Advisory Service, Executive Placement Srvcs
Colleagues
Work History
Senior Regulatory Affairs, Quality Systems and Medical Writing Consultant
469 west Huron St, Chicago, IL 60654
Regulatory Affairs and Medical Writing Consulting Project Experience
Project 3 - Senior Regulatory Specialist Submissions (most recent)
Authored IVD pre-clinical testing summary reports f...
from Sep 2018
Senior Manager Regulatory Affairs
Responsible for regulatory submissions to FDA and other international health authorities for molecular biology infectious disease IVD products with focus on instrumentation and software. Sup...
Jul 2017 — Jul 2018
Senior Manager Regulatory Affairs
Responsible for regulatory submissions for all combination products. Managed IND for small molecule therapeutic product. NDA/IND experience.
Dec 2015 — Jul 2017
Regulatory and Clinical and Quality Consultant
Projects included remediation for clients under FDA Consent Degree, Warning Letter, and Corporate Integrity Agreement.
Jan 2010 — Dec 2015
Associate Director Regulatory Affairs and Compliance Manager Quality Systems
168 3Rd Ave, Waltham, MA 02451
Directed regulatory affairs, compliance and quality systems departments including document control, supplier quality, labeling, auditing, regulatory submissions, country registration, and re...
Jul 2006 — Dec 2009
Quality Systems Consultant
Led regulatory team to remediate three software systems to 21CFR Part 11 compliance which resulted in successful removal of FDA warning letter.
Developed new quality document system for Di...
Jul 2003 — Jul 2006
Publication Coordinator
Indianapolis, IN
Performed scientific writing and coordination duties for manuscript submissions to journals including successful publication of all phase III clinical studies for SNRI antidepressant.
Jul 2001 — Jul 2003
Senior Medical Writer, Regulatory Associate, Clinical Research Associate, Publication Coordinator
4545 Creek Rd, Cincinnati, OH 45242
Advanced through positions of increasing responsibility in regulatory, quality and clinical division. Conducted study initiation, monitoring, completion, and reporting of medical device clin...
Mar 1996 — Jul 2001
Senior Medical Writer
2 P And G Plz, Cincinnati, OH
Regulatory Services Wrote clinical study final reports for FDA submissions, clinical investigator brochures, study protocols and amendments to IND submissions.
Jan 1994 — Jan 1996
Senior Medical Writer
4545 Creek Rd, Cincinnati, OH 45242
Labeling and regulatory support.
Oct 1992 — 1994
Senior Technical Writer Labeling
Wrote operator's manuals, application sheets, package inserts, training guides and labeling for clinical chemistry, and immunology products including that for PMA and 510k submission.
Aug 1988 — Oct 1992
Education
1984 — 1987
Occupations
Executive
Deputy Director
Farmer and Animal Care
Fisher
Deputy Manager
Chief Executive
Skills
Fda
Capa
Regulatory Affairs
Quality System
Validation
21 Cfr Part 11
Quality Assurance
Gxp
Medical Devices
Biotechnology
Gmp
Pharmaceutical Industry
Regulatory Submissions
Computer System Validation
Glp
Fda Gmp
Quality Management
Quality Auditing
Clinical Trials
Pharmaceutics
Regulatory Requirements
Auditing
Quality Control
Sop
Technology Transfer
Document Management
Lifesciences
R&D
Life Sciences
Consent Decree
Lims
Iso 13485
Laboratory Quality Assurance
Software Documentation
Laboratory
Biopharmaceuticals
Ind
Drug Development
Regulatory Documentation
Remediation
Data Integrity
Compliance Remediation
Gcp
Documentation Practices
Iso
Gamp
Laboratory Automation
Computer Systems Validation
Usp
FAQs about Jackie McCulloch
What is the main profession of Jackie McCulloch?
The expert is a Regulatory Affairs Associate.
What are the main profession of The professional?
These person's professions are Executive and Deputy Director
Where does Jackie McCulloch currently live?
Jackie McCulloch lives in Washington, DC.
What is the expert's email?
The expert's email is ja**@sbcglobal.net and ja**@thermofisher.com.
How many companies did Jackie McCulloch work at?
Jackie McCulloch worked at 13 jobs.
Where has Jackie McCulloch studied?
Jackie studied at the Purdue University from 1984 to 1987.
What are the certifications of Jackie McCulloch?
The professional received the following certifications: Rac, Rabaqs Certified Iso 13485 Lead Auditor, Medical Writer, Medical Technologist Ascp, and Rac-Us.
Are there any industries Jackie McCulloch is connected to?
This person works in Research industry.