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QA/RA Director

Real Staffing Chicago Full-Time
$130,000.00 - $170,000.00 / year
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Director of Quality and Regulatory

Direct hire

Class II devices

Are you a strong leader that excels in motivating a team? Do you have an entrepreneurial spirit? A Medical Device company in the St. Charles, IL area is currently hiring for a Director of Quality and Regulatory Assurance.

Responsibilities:

  • Strategy and execution of Quality and Regulatory compliance for the site
  • Authoring 510Ks submissions
  • Work in a cross functional, Matrix capacity with core project teams to manage life cycle from development to commercialization
  • Manage gap analysis and risk assessments
  • Interact directly with the FDA on submission responses and information requests
  • Collaborating with R&D and Operations around existing and new products
  • Possessing a strong ability to influence key decision makers

Requirements:

  • Bachelor's in Engineering, Medical, Science, or Regulatory discipline preferred
  • Management and supervisory experience
  • Technical file authorship
  • ISO 13485 - some 2016 regulation exposure - 21CFR 820
  • Regulatory experience in 510k authorship
  • EtO/Gamma experience: worked through the validation protocols
  • MDD to MDR 2020: Strong MDD experience and knowledgeable of MDR 2020

If you would be interested in exploring this exciting opportunity, please apply directly with an attached resume and the best time to reach you.

Sthree US is acting as an Employment Agency in relation to this vacancy.

 

Skills required

Good Manufacturing Practices
Operations
Technical Services
Corrective And Preventive Actions
Hazard Analysis And Critical Control Points
Manufacturing
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Job ID: RE-33199079

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Real is a global leader in the provision of pharmaceutical, biotechnology and medical devices recruitment services. We are one of the world’s most extensive pharma, biotech and medical devices recruiters and have one of the largest networks of specialist recruiters globally.

Our premise is a simple one: by recognizing talent and valuing relationships we are able to consistently deliver local, global and industry expertise which in turn ensures success time after time.

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