Intellectt Inc

Jr. Regulatory Affairs Associate

Intellectt Inc Abbott, TX
Intellectt Inc

Jr. Regulatory Affairs Associate

Intellectt Inc Abbott, TX
5 months ago 35 applicants
See who Intellectt Inc has hired for this role

Role: Regulatory Affairs Associate

Location: Abbott Park, IL - 60064-3500

Duration: 11 Months

Shift Timings: 8:00 AM to 5:00 PM

Job Description

  • Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.
  • Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports).
  • Review/approval of engineering study protocols/reports and validation study protocols/reports.
  • Review and approval of manufacturing changes for Class III implantable medical devices.
  • May require an advanced degree and 5-8 years of direct experience in the field.
  • Recent experience with Class III implantable medical devices
  • Proven successful track record of authoring/submission/approval of Class III implantable PMA supplements
  • knowledge of FDA PMA guidance documents and CFR regulations.
  • Relies on extensive experience and judgment to plan and accomplish goals.
  • Performs a variety of tasks.
  • May lead and direct the work of others.
  • A wide degree of creativity and latitude is expected.
  • Typically reports to a manager or head of a unit/department.

  • Seniority level

    Associate

  • Employment type

    Full-time

  • Job function

    Legal

  • Industries

    Staffing and Recruiting

Referrals increase your chances of interviewing at Intellectt Inc by 2x

See who you know

Get notified about new Regulatory Affairs Associate jobs in Abbott, TX.

Sign in to create job alert

Similar Searches

Looking for a job?

Visit the Career Advice Hub to see tips on interviewing and resume writing.

View Career Advice Hub