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Regulatory Affairs Associate
Contract: Alameda, California, US
Salary Range: 35.00 - 40.00 | Per Hour
Job Code: 332632
End Date: 2024-04-10
Job Status: Expired
This Job is no longer accepting applications
To discuss more about this job opportunity, please reach out to Chitrank Rastogi (LinkedIn URL - https://www.linkedin.com/in/chitrank-rastogi-55119a102/), email your updated resume at Email - chitrank.rastogi@collabera.com or give me a call at (425) 523-1648. Thank you!
Pay Range - $35 to $40/hr. (negotiable)
Job Description:
Job Roles & Responsibilities:
This role will provide quality, compliance and regulatory support to the Regulatory Affairs organization by:
- Monitoring changing regulations (emerging regulatory issues, trends) in rest of the world geographies and translating regulatory requirements into the quality system.
- Driving implementation of new international regulatory requirements, ensuring procedures are current and regulatory requirements and guidance’s are met.
- Fulfilling international submission deliverables for product registration renewals and for regulatory emerging issues where multiple medical devices require submission.
- Driving quality system process improvement initiatives.
Initiatives include but are not limited to:
- Establishing emerging issues in our quality system.
- Maintaining the quality system procedures (e.g. change management).
- Liaising with cross-functional partners, distribution centers, and international affiliates to obtain/align on international regulatory requirements.
- Troubleshooting with regulatory affiliates.
- Participating in RA projects.
- Role has a potential for investigating non-conformances (CAPAs) and implementing mitigations.
- Exposure to Quality Systems, a Quality role, or a Compliance role is a plus.
Job Requirement
- Regulatory Affairs Associate
- Regulatory Affairs
- international regulatory
- change management
- Quality
- CAPA
- Compliance
- submission
- Pharma
- Pharmaceuticals
- Medical Device
Reach Out to a Recruiter
- Recruiter
- Phone
- Chitrank Rastogi
- chitrank.rastogi@collabera.com
- 4255231648
This Job is no longer accepting applications
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