4 Regulatory Affairs Specialist III Jobs in North Chicago, IL
CONFLUX SYSTEMS is Hiring a Regulatory Affairs Specialist III Near North Chicago, IL
Position OverviewJoin our team as a Regulatory Affairs Associate for a 12-month duration with potential for extension. In this role, you will be responsible for managing applications and liaising with government entities for the regulatory process of products requiring approval. Tasks include authoring and submitting PMA supplements, reviewing engineering and validation study protocols/reports, and approving manufacturing changes for Class III implantable medical devices.
QualificationsThe ideal candidate will possess an advanced degree and 5-8 years of direct experience in regulatory affairs. Recent experience with Class III implantable medical devices is required, along with a successful track record of authoring, submitting, and gaining approval for Class III implantable PMA supplements. Familiarity with FDA PMA guidance documents and CFR regulations is essential for this role.
Responsibilities
- File necessary applications and manage government interactions for product approvals
- Author and submit PMA supplements, including 30-day Notice, Real-Time Reviews, and 180-Day Supplements
- Review and approve engineering and validation study protocols/reports
- Approve manufacturing changes for Class III implantable medical devices
- Utilize extensive experience and judgment to plan and achieve goals
- Lead and guide the work of others when necessary
- Demonstrate creativity and independence in work approach
Employment Type: Contractor
Job Summary
Contractor
$90k-114k (estimate)
07/08/2024
09/30/2024
conclavia.net
Cumming, GA
Related Companies
The job skills required for Regulatory Affairs Specialist III include Regulatory Affairs, etc. Having related job skills and expertise will give you an advantage when applying to be a Regulatory Affairs Specialist III. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Regulatory Affairs Specialist III. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Regulatory Affairs Specialist III positions, which can be used as a reference in future career path planning. As a Regulatory Affairs Specialist III, it can be promoted into senior positions as a Regulatory Affairs Specialist IV that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Regulatory Affairs Specialist III. You can explore the career advancement for a Regulatory Affairs Specialist III below and select your interested title to get hiring information.
Similar Jobs
Popular Articles
