Regulatory Affairs Associate Job at Intellectt INC, Lake Forest, IL

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  • Intellectt INC
  • Lake Forest, IL

Job Description

Hello This is Komal from Intellectt we have an opening for a Regulatory Affairs Associate in Lake Forest, IL. Please find the job details and description below and if interested You can reach me at [email protected] or call me at +1(732)-813-9025.


Role:
Regulatory Affairs Associate

Location: Lake Forest, IL (Conway Park)

Duration: 12 Months

Job Description

The Regulatory Affairs Associate is responsible for managing applications and interactions with government agencies to obtain approvals for medical products.



Key responsibilities include:

  • Preparing and submitting PMA supplements such as 30-Day Notices, Real-Time Reviews, 180-Day Supplements, and Annual Reports.
  • Reviewing and approving engineering and validation study protocols/reports.
  • Managing regulatory submissions and approvals for Class III implantable medical devices.
  • Ensuring compliance with FDA PMA guidance documents and CFR regulations.
Qualifications
  • Advanced degree preferred with 5-8 years of relevant experience.
  • Proven track record in submitting and obtaining approvals for Class III implantable medical devices.
  • Strong knowledge of FDA regulations and guidance documents for PMA submissions.
  • Ability to plan and execute tasks with minimal supervision.
  • Creativity and decision-making skills, with the ability to lead and collaborate effectively.

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