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Quality /Regulatory Affairs/Medical Device
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Location: Elkton, MD
Pay Rate: Contract: 79.33 to 84.13 $/hr
Salary: 165.00 to 175.00 K$/yr
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Position Type/ Job Duration: Direct hire
Education Required: BS 
Years Experience Required: 0

Job Posted: 3/21/2018
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Apply Deadline: 04/12/2018
Job #: 138329MTC
Job order status: Client is actively seeking candidates
Relocation available: Not Available

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Permanent position: We are searching for a Senior Director of Quality and Regulatory Affairs in Elkton, MD. This is a direct hire role that provides great benefits and relocation assistance.


  • Oversight of all Quality and Regulatory Affairs functions, including but not limited to product safety, regulatory strategy and execution, investigation of serious accidents, improving product quality through complaint investigation, resolution, CAPA management, internal auditing, and acceptance activities.
  • Demonstrate a primary safety and product quality by maintaining compliance to the Quality Policy and all other documented quality and processes procedures.
  • Ensure that quality and regulatory compliance activities are properly resourced and prioritized across the organization.
  • Design and implementation of Quality Policies and Procedures for division wide quality and regulatory affairs
  • Lead the decision making process concerning departmental policies for the Quality and Regulatory Affairs


  • Bachelor's Degree is required, preferably in Biomedical Engineering, Quality or Regulatory Affairs.
  • 7+ years of Quality Management experience, with some director level experience
  • 10+ years of experience specifically in Medical Device Quality and Regulatory Affairs, preferably class II or III medical devices


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