Regulatory Affairs Associate - Remote
Intellectt Inc
Remote
regulatory
remote
supplements
class iii
remote
protocols
medical
medical devices
devices
asap
regulatory
pm
government
March 16, 2023
Intellectt Inc
Garland, Texas
Hi,
Greetings of the day
This is Gowri Sankar from Intellectt INC. Please check out the following requirement and let me know your interest ASAP
Role: Regulatory Affairs Associate
Location: Abbott Park, IL 60064 (Remote)
Shift Timings: 8 AM to 5 PM
Remote with 1 day at office (Plymouth, MN or Maple Grove, MN)
Job Description
Greetings of the day
This is Gowri Sankar from Intellectt INC. Please check out the following requirement and let me know your interest ASAP
Role: Regulatory Affairs Associate
Location: Abbott Park, IL 60064 (Remote)
Shift Timings: 8 AM to 5 PM
Remote with 1 day at office (Plymouth, MN or Maple Grove, MN)
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, and 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.
- Bachelor's required.
- 3 to 5 years Addressing Regulators abroad, direct submissions Internationally / Device exp preferred, will consider Pharma.
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