Indotronix Avani Group
Regulatory Affairs Specialist
Indotronix Avani Group, Irvine, California, United States, 92713
Talent Acquisition Executive | Talent Acquisition
Regulatory Affairs is responsible for planning, coordinating and implementing regulatory Submissions for products that require government approval.
Demonstrates working knowledge of healthcare-related regulations
Demonstrates in-depth knowledge of preparing a submission
Demonstrates in-depth knowledge of industry and competitive products Applies relevant regulations and statutes to further product submissions of basic to medium complexity Contributes to the strategic direction of regulatory pathway development Refines and conforms the preliminary data used in the submission process
Translates technical data and descriptions into reviewer-friendly content Helps to ensure that the appropriate regulatory requirements for the submission are met Interacts with regulatory body to help further product approvals or clearance
Has in-depth experience, knowledge and skills in own job family Applies knowledge and skills to a wide range of standard and non-standard situations Works independently with minimal guidance Usually determines own work priorities Acts as a resource for colleagues with less experience
Seniority level:
Associate
Employment type:
Contract
Job function:
Legal and Management
Industry:
Medical Equipment Manufacturing
Location:
Irvine, CA Salary:
$69,510.00 - $126,382.00 Posted:
1 day ago
#J-18808-Ljbffr
Demonstrates working knowledge of healthcare-related regulations
Demonstrates in-depth knowledge of preparing a submission
Demonstrates in-depth knowledge of industry and competitive products Applies relevant regulations and statutes to further product submissions of basic to medium complexity Contributes to the strategic direction of regulatory pathway development Refines and conforms the preliminary data used in the submission process
Translates technical data and descriptions into reviewer-friendly content Helps to ensure that the appropriate regulatory requirements for the submission are met Interacts with regulatory body to help further product approvals or clearance
Has in-depth experience, knowledge and skills in own job family Applies knowledge and skills to a wide range of standard and non-standard situations Works independently with minimal guidance Usually determines own work priorities Acts as a resource for colleagues with less experience
Seniority level:
Associate
Employment type:
Contract
Job function:
Legal and Management
Industry:
Medical Equipment Manufacturing
Location:
Irvine, CA Salary:
$69,510.00 - $126,382.00 Posted:
1 day ago
#J-18808-Ljbffr