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

UWNCQWlvak9zY0hpN09lUTQwc2VxV3BVZEE9PQ==
  • 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.

Job Tags

Similar Jobs

Best Buy

Geek Squad Advanced Repair Technician Job at Best Buy

 ...Job Description As a Geek Squad Advanced Repair Technician (Agent), youll work at our local Best Buy store to provide technology support...  ..., repair devices and help customers both in-person and over the phone Establish and maintain consistent rhythms for timely follow-... 

Ecolab Inc.

Field Service Representative Job at Ecolab Inc.

 ...assurance plans Provide technical support to customers; identifying and resolving customer pain points, escalating as required Install, calibrate, and maintain chemical feed equipment and process monitoring equipment at customer accounts Position Details:... 

Kodiakgas

Business Development Manager, AMS Job at Kodiakgas

 ...company's goals and objectives, identifying customers with strategic alliance potential. Customers should have growth potential for AMS Parts and Service as well as revenue through Kodiak's other service offerings (CGC, Station Construction, Contract Treating, Cooler rental... 

Summit Energy Group LLC

Solar Installer Job at Summit Energy Group LLC

 ...Job Description Description: Company Overview : At Summit Energy our core values create the framework for the way in which we work...  ...chance to grow with an industry leader! Summit Energy is seeking a Solar Installer to work with us to create the best experience for our... 

Express Employment

Certified Medical Assistants Job at Express Employment

 ...Job Description Job Description Located in Honolulu, HI Salary: Up to $26/hr Calling All Certified Medical Assistants! Are you ready to make a difference while advancing your career? Join Hawaii's largest healthcare organization with locations across the island...