Job Openings

Quality Management / Regulatory Affairs Manager

Waco, TX 76712

Posted: 04/07/2021 Employment Type: Direct Hire Function: HSE/Quality Assurance Job Number: 20495 Pay Rate: $70,000-$80,000

Job Description

Quality Management Representative/QA and Regulatory Affairs Manager 

Position Type: Direct Hire

Position Location: Waco, TX

Position Salary: $70,000 – $80,000 (Depending on Experience)

QMR/Regulatory Affairs Manager has primary responsibility as Quality Management Representative for ISO13485, 21 CFR 820 quality systems, and the primary contact for regulatory agencies and certifying bodies including, but not limited to US FDA, Thai FDA, Intertek, EU regulators and CE marking partners. The Quality Control/New Product Development Coordinator will report to the QMR/Regulatory Affairs Manager.

Responsibilities:

  • Perform all functions required as QMR including, but not limited to Quality Management reporting as required, hands-on maintenance of the quality systems, and all quality and regulatory reporting and inquiries.
  • Lead auditor and audit trainer for all team members
  • Interface with regulatory agencies for all issues (registration, device reporting, listings, 510k submissions, 483’s, CE marking, and any other regulatory related actions)
  • Manage the work of the Quality Control/New Product Development Coordinator including new product development/project management, the finalization and maintenance of finished product specifications, document control, issuance of certificates of analysis/compliance, and technical documents such as technical data sheets as required.
  • Coordinate quality system and new product development projects with counterparts in Thailand
  • Lead special projects regarding regulatory reporting and other issues related to compliance with US and European regulations, and assist with the quality system as needed.
  • Lead new product development for medical devices.
  • Reporting on hazardous material storage compliance to Federal, state and local agencies as required
  • Manage MRB (Material Review Board) area.  Actively work to correct product issues and release products.
  • Other projects as assigned involving Quality, Regulatory Affairs and New Product Development

Requirements:

  • Bachelor’s degree in a science related background, will consider other related degrees
  • 3+ years working experience in regulatory and/or product development/product manufacturing working with FDA and ISO regulations
  • Prior experience with documentation and project management within a life science company that maintains an ISO13585, cGMP quality system
  • Working knowledge of US FDA medical device for manufacturing (cGMP & FDA 21CFR 820) and packaging.
  • Familiarity with ISO 13485 and ISO 9001.
  • High level of organization skills required
  • Strong Ability to work independently in a fast paced, high pressure environment is required
  • Advanced knowledge of Microsoft Excel, Word and Outlook
  • Advanced communication and problem-solving skills are required for the role

Benefits:

  • Full Benefits (Medical, Dental, Vision)
  • 401K + Matching
  • Relocation Assistance

Due to the high volume of applications we typically receive, we regret that we are not able to personally respond to all applications. However, if you are invited to take the next step in the process, you will typically be contacted within 3 weeks of submitting your application

Meet Your Recruiter

Robert Fragoso
Recruiter - Murray Technical

Specializing in placing talent in Engineering, IT, Manufacturing, Operations, and Sales roles.
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