Priyangi Dave

Regulatory and Compliance Specialist with 3+ years of experience across medical device, pharmaceutical, clinical research, and quality environments, supporting regulatory compliance, quality documentation, product and study documentation, audits, CAPA, deviations, and controlled records. Experienced in Health Canada and international regulatory requirements, ICH-GCP, medical device compliance, regulatory submissions, TMF/ISF management, SOPs, and inspection readiness. Strong ability to assess regulatory requirements, identify compliance gaps, coordinate corrective actions, and collaborate cross-functionally with Quality, Clinical Operations, Regulatory Affairs, and business teams.

Knowledge of Canadian regulatory frameworks including Medical Devices Regulations, TDG, WHMIS, Controlled Goods Program (CGP), and regulated product compliance.

Regulatory Compliance Specialist (Europe Region & Globally) - Meril Life Science - Toronto

(2023-01 - 2026-12)

• Conducted regulatory and compliance assessments of medical device and clinical documentation, reviewing requirements against applicable Health Canada, ICH-GCP, EMA, MHRA, and CDSCO frameworks and identifying compliance gaps requiring corrective action.
• Managed and reviewed essential regulatory documentation, controlled records, Investigator Site Files (ISF), TMF documentation, SOPs, and submission packages, ensuring accuracy, completeness, version control, and inspection readiness across multinational studies.
• Supported regulatory submissions, product/study documentation, quality investigations, deviations, and CAPA follow-up, coordinating with Regulatory Affairs, Quality, Clinical Operations, and cross-functional stakeholders to resolve compliance issues within defined timelines.
• Conducted 35+ on-site, remote, and centralized compliance/monitoring reviews and resolved 200+ documentation and clinical data queries, strengthening GCP, protocol, regulatory, and quality compliance across assigned studies.
• Supported regulatory and quality audits, inspection readiness, process improvement, and regulatory change implementation, maintaining accurate compliance records and submission-ready documentation for internal and external stakeholders.

Regulatory study startup associate - Cliantha Research - Toronto

(2025-01 - 2025-12)

• Reviewed regulatory and essential documents across 4 concurrent Phase I–III studies, assessing completeness, accuracy, consistency, and compliance requirements before site activation.
• Supported regulatory and ethics submissions, maintaining submission trackers, document packages, approval records, and controlled documentation to ensure timely and compliant study start-up.
• Managed TMF/ISF documentation, version control, document reconciliation, and deficiency tracking, following outstanding items through resolution and maintaining audit-ready records.
• Coordinated with cross-functional study teams to identify regulatory gaps, deviations, and documentation deficiencies, supporting CAPA and corrective-action follow-up within required timelines.
• Contributed to on-time site activation and inspection readiness by ensuring regulatory documentation was complete, current, accurately filed, and aligned with study and applicable regulatory requirements.

Clinical Trial Assistant - Evolve Life Science - India

(2022-01 - 2023-12)

• Maintained eTMF and essential regulatory documentation in Veeva Vault across Phase II/III clinical studies, ensuring document completeness, accuracy, version control, and audit readiness.
• Supported regulatory and ethics submissions, maintaining submission trackers, approval documentation, correspondence, and controlled study records in accordance with applicable requirements.
• Supported site activation, study start-up, document collection, and regulatory record maintenance, ensuring timely availability of required essential documents.
• Collaborated with Clinical Operations, Regulatory Affairs, and study teams to maintain compliant documentation, inspection readiness, and overall study record integrity.

Professional Diploma - Regulatory Affairs & Clinical Research - Conestoga College

Professional Diploma - Healthcare Project Management & Leadership - Conestoga College

MBA - Healthcare Management

B.Sc. - Microbiology