Arlette Azua

About Arlette Azua

Regulatory Affairs professional with extensive experience in the pharmaceutical, medical…

Experience

1. Staff Regulatory Affairs Specialist

   Dexcom

   Nov 2022 — Present · San Diego, CA, US

   Led the successful submission of IDEs, Progress, and Annual Reports to the FDA, ensuring timely delivery and compliance with regulatory expectations.• Maintained communication with FDA, BSI representatives, and internal stakeholders to confirm review completion and next steps.• Worked closely with cross-functional teams, including Regulatory Operations, Supplier Quality, and R&D, to coordinate implementation deliverables and post-approval activities.• Authored and reviewed multiple Change Order Plans (COPs), coordinating supplier qualifications and validation documentation across global markets.• Collaborated with suppliers and internal teams to evaluate extractables and leachables, ensuring device-level compliance.• Participated in high-level regulatory meetings, providing input on quality-of-life claims, comparator definitions, and substantiation strategies. Helped finalize disclaimers and approval workflows for international markets.• Managed global regulatory strategies for CGM medical devices and addressed regional filing issues.• Determined appropriate regulatory assessments and pathways for Dexcom’s CGM device line.• Coordinated regulatory activities for designated products within the region.• Prepared and submitted regulatory documents such as LTF, Annual Reports, and EU Change Notices.• Oversaw content management of eCTD documents for combination projects included in filings.• Worked with Marketing, Legal, and Medical Affairs representatives to develop advertising and promotional materials compliant with requirements for US and EMEA regions.• Prepared, reviewed, and quality-controlled regulatory submissions in alignment with regulatory and departmental standards, including IDEs, 510ks, and amendments to Technical Documentation.• Assessed regulatory options and risks for moderately complex projects and provided updates to regulatory management and project teams.• Maintained current knowledge of changes in the regulatory environment.