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January 7th, 2016

Medical Device Compliance Auditor for Boston or Minneapolis Area

Medical Device Quality and Regulatory Compliance professionals needed for two opportunities to assess non-active medical devices and their manufacturers per the European Medical Devices Directives, other applicable Regulatory Systems and International standards, including related client and project management

  • 50% Audit
  • Perform regulatory audits of clients per European Medical Device Directives (AIMD, MDD, IVDD), Canadian Medical Device Regulations (CMDR), Japanese Pharmaceutical Affairs Law (JPAL) and International quality system standards (e.g. ISO 13485)
  • 50% Technical Document Review
  • Perform evaluations of regulatory submissions including: Clinical, Design Dossier, Technical File Review

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November 13th, 2015

GMP Regulations for Friday the 13th

Happy Friday the 13th! Remember, if you need a GMP or Quality specialist who knows the regulations below then don’t be scared. Call MEIRxRS. Read the rest of this entry »

August 17th, 2015

FSMA Compliance Workshop 2015

 

FSMA Compliance Workshop

Download the PDF flyer

FSMA will impact your food business. Find out how and what to do about it. This is a free half day workshop on Food Safety and Modernization Act (FSMA) compliance.

Breakfast and refreshments are sponsored by the American Society for Quality (ASQ) Food, Drug & Cosmetic Division, the Quality Leaders Network (QLN) Food Group, RxRS Apprenticeship Program and Food Safety Net Services.

Overview

FSMA is designed to insure food quality from the farm to fork. FSMA requires all Read the rest of this entry »

May 15th, 2013

Manager of Regulatory Affairs, Orange County CA

Job Description
• Manage Regulatory Affairs activities to include, but not limited to:
o Canadian Regulatory Submissions
o International Regulatory Submissions Teams
o Emerging Market Regulatory Strategy
o Global Product Assessments and Approvals
o Product Development Teams
o Regulatory Guidance for
 Change Control
 Product Review Boards

Requirements
• BS degree minimum in life sciences, advanced degree preferred
• 8+ years of experience in medical device industry
• FDA and Global Regulation requirements for Medical Device product lifecycle
Please contact:
Lewie Casey
Talent Manager
Phone: 818-552-4173
Email: lcasey@medexecintl.com

May 15th, 2013

Director of Regulatory Affairs, Orange County CA

Job Description
• Direct Regulatory Affairs activities to include, but not limited to:
o Domestic and Global Regulatory Intelligence
o Regulatory Strategy
o Regulatory Communication
o Global Read the rest of this entry »

May 8th, 2013

Clinical/Regulatory Medical Writer, Los Angeles CA

This position is for a medical writer with clinical and regulatory writing experience (not preclinical) and  will be based at Headquarters in the Los Angeles area (not home-based). Write clinical study reports, data summary reports, publications and promotional materials.

 

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