Job Title - Regulatory Affairs Associate
Location- Santa Clara, California 95054
Pay rate - $45/hr on W2 (without Benefits)
Shift - 8 am to 5.00 pm
Duration- 12+ Months of contract role
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.
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
