Regulatory Affairs Operations Specialist

Job Title :Regulatory Affairs Operations Specialist Location: Santa Clara CA Duration: 12 Months We are seeking a detai loriented and proactive Regulatory Affairs Operations Specialist to support our Regulatory Affairs team. This role plays a key part in ensuring compliance with international regulatory requirements, maintaining highquality documentation standards, and supporting crossfunctional initiatives across global markets. Candidates should have below criteria * 5+ years of experience in Regulatory Affairs * Hands-on experience with regulatory labeling, specifically addendum labeling, supplemental labeling, and/or execution of labeling changes * Demonstrated familiarity with regulated medical device environments and quality systems. Given the nature of the work, it's important that candidates are seasoned and can operate with minimal ramp-up.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 panfranchise requests for multiple products, including scheduling and facilitating meetings with international stakeholders Submit and track addendum labeling requests. Liaise with crossfunctional 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 ofAuthorization (LoA), Power of Attorney (PoA), tenders, controlled substances and evidence of conformance letters. Maintain uptodate 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 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: Independent Troubleshooting Critical thinker Ability to drive a problem through resolution and implement mitigations Ability to handle multiple streams simultaneously