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Regulatory Affairs Specialist
intellectt Forest, IL
$101k-129k (estimate)
Full Time | Business Services 4 Days Ago
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intellectt is Hiring a Regulatory Affairs Specialist Near Forest, IL

This is Jahera and I'm a recruiter at Intellectt, Inc. Please find the job description and reach out to me with an updated copy of your resume. You can send it to jahera@intellectt.com or call me at 1(732) 276-1791
Role: Regulatory Specialist IILocation: Lake Forest, IL - 60045Duration: 12 Months Shift Timings: 8am to 5 pm ResponsibilitiesJob Description:
  • Prepare documentation for EU Technical Files and international product registrations, adhering to IVDR regulations.
  • Offer regulatory support for diagnostic product development and commercial products.
  • Develop regulatory strategies for product development and modifications to ensure EU and international clearance/approval.
  • Assist regional regulatory teams with submissions, renewals, and amendments.
  • Research and communicate scientific and regulatory information for submission documents.
  • Compile and publish materials for submissions, renewals, and registrations.
  • Maintain existing marketing authorizations.
  • Assess product changes for regulatory compliance.
  • Develop internal procedures and tools.
  • Conduct informational or training sessions.
  • Organize and maintain department files.
  • Support the implementation of Abbott Quality Management System.
Education
  • Bachelor’s Degree in relevant technical field or equivalent experience.
  • 4 years’ Regulatory Affairs experience.
  • Strong knowledge of IVDR and EU regulatory requirements.

Job Summary

JOB TYPE

Full Time

INDUSTRY

Business Services

SALARY

$101k-129k (estimate)

POST DATE

05/30/2024

EXPIRATION DATE

10/28/2024

WEBSITE

intellectt.com

HEADQUARTERS

ISELIN, NJ

SIZE

200 - 500

FOUNDED

2018

CEO

KIRAN MADALA

REVENUE

$5M - $10M

INDUSTRY

Business Services

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About intellectt

Intellectt Inc. was founded to set a new standard in Consulting and Staffing Industry. Our company is made up of dreamers, calculated risk-takers, diligent people that go to fight for the brand of our client. Intellectt Inc. and our affiliated brands provide innovative talent solutions that make our clients businesses better. Our verticals include Healthcare and IT. We exist to become the finest and most esteemed staffing company across the USA and we look forward to putting our talents to use to push your organization forward.

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