Please Contact To discuss this amazing opportunity, reach out to our Talent Acquisition Specialist Ram Sasane at email address can be reached on # .
We have Contract Role Regulatory Affairs Associate (Contingent Worker) for our client at Santa Clara, CA. Please let me know if you or any of your friends would be interested in this position.
Position Details :
Regulatory Affairs Associate (Contingent Worker) - Santa Clara, CA
Location : Santa Clara, CA 95054
Project Duration : 12+ Months of contract
Pay Rate :$40/hr. W2
Regulatory Affairs Associate (Contingent Worker)
We are seeking a detail-oriented and proactive Regulatory Affairs Operations Specialist (Contingent Worker) to support our Regulatory Affairs team. This role plays a key part in ensuring compliance with international regulatory requirements, maintaining high-quality documentation standards, and supporting cross-functional initiatives across global markets.
Summary of Responsibilities:
The Regulatory Affairs Operations specialist will provide support to the Regulatory Affairs organization by
- Drive implementation of new international regulatory requirements, ensuring procedures are current and compliant with applicable guidance and requirements.
- Lead quality system process improvement initiatives
- Prepare KPI dashboards and maintaining a pulse on internal Regulatory Affairs (RA) metrics.
- Coordinate pan-franchise requests for multiple products, including scheduling and facilitating meetings with international stakeholders
- Submit and track addendum labeling requests.
- Liaise with cross-functional partners, distribution centers, and international affiliates to align on regulatory requirements, documentation, addendum labeling, and regulatory letters.
Pan Franchise Specialist Santa Clara
Key tasks and Initiatives:
Initiatives include but are not limited to:
- Prepare and submit certificates to Foreign Governments (CFG) requests via the FDA database.
- Maintain tracker and review Declarations of conformity (DoC):
- Ensure adherence to Good Documentation Practices (GDP)
- Manage translation requests using the Acolad portal
- Review EU MDR DoC translations for accuracy and consistency
- Review Regulatory Letters and maintain tracker for Letter of Authorization (LoA), Power of Attorney (PoA), tenders, controlled substances and evidence of conformance letters.
- Maintain up-to-date trackers, SharePoint sites, and documentation repositories
- Support change management activities, including change orders (CO) for DoC templates and quality system procedures
- Establishing emerging issues within the quality system,
- Participate in RA projects and continuous improvement initiatives
- Troubleshoot regulatory issues in collaboration with international regulatory affiliates
This role has a potential for investigating nonconformances (CAPAs) and implementing mitigations. Exposure to Quality Systems, a Quality role, or a Compliance role is a plus.
Skills:
- Independent
- Troubleshooting
- Critical thinker
- Ability to drive a problem through resolution and implement mitigations
- Ability to handle multiple streams simultaneously
To discuss this amazing opportunity, reach out to our Talent Acquisition Specialist Ram Sasane at email address can be reached on # .
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