Regulatory Affairs Associate
HireTalent - Staffing & Recruiting Firm, California, MO, United States
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
#J-18808-Ljbffr
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
#J-18808-Ljbffr