Regulatory Affairs
Regulatory Affairs
Intellectt Inc
North Chicago, IL
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Role: Regulatory Affairs Associate
Duration: 8 Months
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.
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Thanks & regards,
Teja Recruiter | Intellectt Inc | Ph: +1 732-746-0641
Add: 517 Route 1 South, Suite 1115 Iselin, NJ 08830
Email: vekatateja@intellectt.com
Linked in : https://www.linkedin.com/in/venkat-teja-tadivaka-2a97401a9/
Duration: 8 Months
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: +1 732-746-0641
Add: 517 Route 1 South, Suite 1115 Iselin, NJ 08830
Email: vekatateja@intellectt.com
Linked in : https://www.linkedin.com/in/venkat-teja-tadivaka-2a97401a9/
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Seniority level
Mid-Senior level -
Employment type
Full-time -
Job function
Legal -
Industries
Medical Equipment Manufacturing, Medical Practices, and Pharmaceutical Manufacturing
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