17 Regulatory Affairs Associate Jobs in North Chicago, IL
intellectt is Hiring a Regulatory Affairs Associate Near North Chicago, IL
Location: Abbott Park, Illinois - 60064-3500
Duration: 8 Months on W2
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.
Thanks & regards, Teja Recruiter | Intellectt Inc | Ph: 1 732-746-0641Add: 517 Route 1 South, Suite 1115 Iselin, NJ 08830
Email: vekatateja@intellectt.com
Linked in : https://www.linkedin.com/in/venkat-teja-tadivaka-2a97401a9/
Job Summary
Full Time
Business Services
$74k-95k (estimate)
06/02/2024
10/08/2024
intellectt.com
ISELIN, NJ
200 - 500
2018
KIRAN MADALA
$5M - $10M
Business Services
Related Companies
About intellectt
Intellectt Inc. was founded to set a new standard in Consulting and Staffing Industry. Our company is made up of dreamers, calculated risk-takers, diligent people that go to fight for the brand of our client. Intellectt Inc. and our affiliated brands provide innovative talent solutions that make our clients businesses better. Our verticals include Healthcare and IT. We exist to become the finest and most esteemed staffing company across the USA and we look forward to putting our talents to use to push your organization forward.
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