Regulatory Affairs Specialist - Onsite
MILLENNIUMSOFT
Position : Regulatory Affairs Specialist
Location : Irvine, CA
Duration : 10 Months
Total Hours/week : 40.00
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
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
Vacancy posted 3 days ago
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