MillenniumSoft Inc
Regulatory Affairs Specialist - Onsite
MillenniumSoft Inc, Irvine, California, United States, 92713
Regulatory Affairs Specialist - Onsite (Urgent Need)
Join to apply for the
Regulatory Affairs Specialist - Onsite
role at
MillenniumSoft Inc
4 days ago – be among the first 25 applicants
Job Details
Location:
Irvine, CA
Duration:
10 Months
Total Hours/week:
40.00
Shift:
1st Shift
Client:
Medical Devices Company
Job Category:
Clinical
Level of Experience:
Mid-Level
Employment Type:
Contract on W2 (Need US Citizens or GC Holders or GC EAD or OPT or EAD or CPT)
Hybrid onsite:
3 days
Salary:
$69,510.00-$126,382.00
Posting date:
3 days ago
Job Description
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.
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Regulatory Affairs Specialist - Onsite
role at
MillenniumSoft Inc
4 days ago – be among the first 25 applicants
Job Details
Location:
Irvine, CA
Duration:
10 Months
Total Hours/week:
40.00
Shift:
1st Shift
Client:
Medical Devices Company
Job Category:
Clinical
Level of Experience:
Mid-Level
Employment Type:
Contract on W2 (Need US Citizens or GC Holders or GC EAD or OPT or EAD or CPT)
Hybrid onsite:
3 days
Salary:
$69,510.00-$126,382.00
Posting date:
3 days ago
Job Description
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.
#J-18808-Ljbffr