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Hiring _ Senior Regulatory Affairs Specialist _ Remote

Company

Intellectt Inc
Address Lake Forest, IL, United States
Employment type CONTRACTOR
Salary
Category Medical Equipment Manufacturing,Biotechnology Research,Pharmaceutical Manufacturing
Expires 2023-12-04
Posted at 11 months ago
Job Description
Role: Senior Regulatory Affairs Specialist
Location: Abbott Park, IL 60064 (Remote)
Duration: 5 Months on W2

Years Experience:
  • Must have 3-5 years of experiences in Medical Device Regulatory Affairs
Skills
  • Work cross-functionally and in a matrixed environment
  • Have working knowledge in Regulatory Change Assessment in
  • Have working knowledge in EU MDR
  • Have experience with continuous improvement activities
  • Have experience supporting internal and external inspections
  • Have working knowledge in US and EU medical device submissions
Education
  • BA Degree Required
Duties
  • This position will be working with multiple business units to develop, update, and improve regulatory affair processes.
  • Identify opportunities for regulatory affair processes and drive changes to completion.
  • Assist the strategy implementation and operations for regulatory affairs activities, including directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.
  • Update and develop procedures for the regulatory affairs in supporting changes in the regulatory landscape, including EU MDR.
Thanks & Regards,
Kalyan K | Technical Recruiter
Email: [email protected]
Direct: +1 (732) 769-3893
Desk Number: 732-412-6999 Ext: 274
https://www.intellectt.com/
517 Route 1 South, Suite 1115 Iselin, NJ 08830