Regulatory Affairs Specialist

  • location: Deerfield, IL
  • type: Contract
  • salary: $49.80 - $53.90 per hour
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job description

Regulatory Affairs Specialist

job summary:
Quality Compliance Specialist IV

Join this growing team with an open concept environment. If you are an problem solver, organized, and think outside of the box, you might be the right fit for this top 500 company.

 
location: Deerfield, Illinois
job type: Contract
salary: $49.80 - 53.90 per hour
work hours: 9 to 5
education: Bachelors
 
responsibilities:
Job Responsibilities

  • Conducting gap assessments will be the key responsibility.
  • Work with the Device Quality team to upgrade the Software Device quality management system to comply with ISO 13485:2016 and the new Medical Device Regulation in Europe.
  • Activities will include conducting a full gap analysis to both ISO 13485:2016 and the MDR, creating a plan to fill any gaps, and execute to that plan.
  • In addition, provide support for the execution of a compliance gap analysis and remediation of software applications for all of the client.
 
qualifications:
Education & Qualifications

  • Detailed knowledge of both ISO 13485:2016 and the new Medical Device Regulation.
  • At least 5 years of medical device quality experience, with preferred experience with software medical devices.
  • Experience in performing gap analysis, writing planning documents, and executing to global plans.
Benefits

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance
 
skills: Regulatory Affairs Operations
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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