Regulatory Affairs Ops Specialist I

Overview

On Site
$45 - $48
Contract - W2
Contract - 12 Month(s)

Skills

Regulatory Affairs
FDA
REGULATORY OPERATIONS

Job Details

Immediate need for a talented Regulatory Affairs Ops Specialist I. This is a 12+ months contract opportunity with long-term potential and is located in Deerfield, IL(Onsite). Please review the job description below and contact me ASAP if you are interested.
Job ID: 25-80529

Pay Range: $45 - $48/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).

Key Responsibilities:

  • This section focuses on the main purpose of the job in one to four sentences.
  • Under limited supervision responsible for the implementation of regulatory strategies, and resolution of issues pertaining to documents/ packages for regulatory submissions.
  • Produces and evaluates technical and scientific data necessary for regulatory submissions.
  • Assists in the implementation and delivery of new or upgraded systems and processes in support of companies products.
  • This section contains a list of five to eight primary responsibilities of this role that account for 5% or more of the work.
  • The incumbent will perform other duties assigned.
  • Document all system related issues, and identify resolutions
  • Document complex processes and create and manage documentation related to validated systems Participate in identifying solution to meet requirements for systems
  • Participate in system upgrades to assure integrity of data is maintained
  • Assure adequate access and functioning of system tools and version upgrades
  • Provides expertise in ongoing maintenance of electronic record receipt and submission to regulatory authorities
  • Participate as an active team member and provide expertise to project teams as required
  • May verify the maintenance of support systems, libraries and dictionaries
  • Maintain awareness of regulatory requirements and evaluate potential impact to company
  • To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
  • Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
  • Detail oriented


Key Requirements and Technology Experience:

  • Key skills; Regulatory Affairs, FDA, REGULATORY OPERATIONS
  • Technical system skills (e.g. word processing, spreadsheets, databases, online research)
  • Written and verbal communication skills
  • Knowledge of applicable regulations
  • Excellent organizational skills and ability to support multiple projects
  • Ability to contribute to multiple projects from an operations perspective
  • Work independently with minimal direct supervision
  • Strong negotiation and collaboration skills
  • Manage multiple projects and deadlines
  • Ability to identify compliance risks and resolve or escalate when necessary
  • Experience in addressing complex problems or processes Include the education and experience that is necessary to perform the job satisfactorily.
  • Bachelors Degree or country equivalent with a minimum of 5 years in a regulated environment.
  • Scientific or related discipline would be an advantage.

Our client is a leading Healthcare Industry, and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.

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