Job Description

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

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