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Regulatory Specialist

Location : Valley Cottage NY US 10989
Job Type : Temp/Contract to Direct
Reference Code : 21080-BZ1
Compensation : open - 45-55/h
Start Date : 06/20/2022
Hours : Full Time
Required Years of Experience : 3
Required Education : BS Engineering or Science
Travel : No
Relocation : No
Job Industry : Medical Devices

Job Description :


  • Contract to direct position for a Regulatory Specialist for medical device manufacturing.

  • Translate quality and regulatory requirements into quality assurance plans and instructions.

  • Prepare and implement quality standards, operating procedures, work instructions and reporting systems.

  • Conduct quality and regulatory training programs for personnel.

  • Report in-house and field quality data and quality problems, recommend corrective action, and verify effectiveness of solutions.

  • Conduct internal quality and vendor audits on a scheduled basis.

  • Perform other duties as assigned.


Required Qualifications :


  • BS Engineering or Science

  • Internal Company orientation training.

  • Training: ISO-13485 or similar quality system standard and quality auditing.

  • External advanced QSR/GMP/ISO training.

  • Related SOP training.

  • Minimum 3 years experience with quality and regulatory affairs.


  • Intermediate Level Microsoft Office: Excel and Word.  




  • Experience with internal auditing of Quality systems. 





Contact: Bill Zukowsky


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Please send all inquiries to 
BZ@EngineeringResource.com


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