Regulatory Affairs Associate

Please Contact To discuss this amazing opportunity, reach out to our Talent Acquisition Specialist Ram Sasane at email address can be reached on # 630-576-1146.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, CALocation : Santa Clara, CA 95054Project Duration : 12+ Months of contractPay Rate :$40/hr. W2Regulatory 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 initiativesPrepare 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 stakeholdersSubmit 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 ClaraKey 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 portalReview EU MDR DoC translations for accuracy and consistencyReview 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 repositoriesSupport change management activities, including change orders (CO) for DoC templates and quality system proceduresEstablishing emerging issues within the quality system,Participate in RA projects and continuous improvement initiativesTroubleshoot regulatory issues in collaboration with international regulatory affiliatesThis 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:IndependentTroubleshootingCritical thinkerAbility to drive a problem through resolution and implement mitigationsAbility to handle multiple streams simultaneouslyTo discuss this amazing opportunity, reach out to our Talent Acquisition Specialist Ram Sasane at email address can be reached on # 630-576-1146.