Intellectt Inc

Regulatory Affairs

Intellectt Inc Lake Forest, IL
Intellectt Inc

Regulatory Affairs

Intellectt Inc Lake Forest, IL
3 months ago
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Role: Regulatory Affairs Associate Jr

Location: Lake Forest, IL - 60045

Duration: 08 Months

Description

  • Ability to schedule and organize multiple projects Education: BS Engineering or Scientific Duties: Manager regulatory submissions to ensure timely regulatory approval of medical devices.
  • Monitor changing regulations in geographies and translate/communicate these requirements to project development and/or continuous improvement project teams.
  • Ensure all client product and procedures comply with applicable regulatory agency requirements and guidelines.
  • Supports execution of External Regulations Standards and Guidance Documents packages through tracking and monitoring ePAS packages from draft to final closure.
  • Prepares metrics associated with the process for Executive Management Review (EMR)
  • Completes final signature approval of an ePAS package (i.e., FSG Approval)
  • Data review, analysis, and verification.

Education & Experience

  • BS in engineering or scientific degree / 1+ years’ experience in a medical device or similarly regulated industry.
  • Strong analytical and problem-solving skills.
  • Demonstrated competency and working knowledge of Excel, Word, PowerPoint, SharePoint, and Teams.
  • Communicate effectively verbally and in writing. Communicate with diverse audiences and personnel. Write and edit technical documents.
  • Ability to work with people from various disciplines and cultures.
  • Strong attention to detail.

Shaik Aleem

Recruiter

Intellectt Inc

aleem@intellectt.com

Desk Number: 732-412-6999 Ext: 459

Direct Number: 732-813-0353

517 Route 1 South, Suite 1115 Iselin, NJ 08830

___________________________________________________________

In my absence, you may contact Venkat| Lead | 732-631-8229 | Venkat@intellectt.com

  • Seniority level

    Entry level

  • Employment type

    Contract

  • Job function

    Legal

  • Industries

    Staffing and Recruiting

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