Venkata Neelisetti

Regulatory Affairs professional with 6+ years of experience supporting medical device and in vitro diagnostic (IVD) product compliance across Canadian regulated healthcare environments. Experienced in preparing and managing Health Canada Class II-IV Medical Device Licence (MDL) submissions, Medical Device Establishment Licence (MDEL) applications and renewals, regulatory change assessments, product lifecycle management, labeling compliance reviews, and post-market regulatory activities. Proven success interacting with Health Canada, responding to deficiency and information requests, maintaining compliance with ISO 13485 and MDSAP requirements, and collaborating with cross-functional stakeholders to support market access and business objectives.

Working knowledge of FDA medical device regulations, EU MDR requirements, IMDRF guidance documents, and global regulatory frameworks. Experienced using Regulatory Enrolment Process (REP) for medical devices and supporting regulatory strategies for marketed medical device products.

Regulatory Compliance Specialist - Inter Medico - Canada

(2024-02)

• Lead regulatory affairs activities for a portfolio of medical device and IVD products marketed in Canada.
• Completed and managed Health Canada Regulatory Enrolment Process (REP) activities to establish and maintain company and regulatory transactions within ESG NextGen for medical device submissions.
• Experienced in Health Canada Regulatory Enrolment Process (REP), including enrollment creation, account maintenance, dossier setup, and submission management through ESG NextGen.
• Coordinated Health Canada Class II-IV Medical Device Licence submissions, including REP registration and maintenance requirements to support eCTD and non-eCTD submissions.
• Proficient in Health Canada's Regulatory Enrolment Process (REP) for creating, updating, and managing regulatory activities and submission transactions within ESG NextGen.
• Manage Medical Device Establishment Licence (MDEL) applications and renewals to ensure uninterrupted market authorization and regulatory compliance.
• Develop regulatory strategies and submission plans supporting product maintenance and lifecycle management activities.
• Prepare responses to Health Canada deficiency notices, clarification requests, and additional information requests within regulatory timelines.
• Conduct regulatory impact assessments for product, manufacturing, supplier, and labeling changes to determine regulatory requirements and submission obligations.
• Review labeling, product documentation, marketing materials, and promotional content to ensure regulatory compliance.
• Collaborate with quality, technical, supply chain, and commercial teams to support regulatory decision-making and product changes.
• Lead post-market regulatory activities including recalls, incident reporting, risk assessments, and corrective actions.
• Monitor evolving regulations, standards, IMDRF guidance documents, and industry requirements to support proactive compliance initiatives.
• Maintain manufacturer ISO 13485 and MDSAP certifications and support internal and external audits.
• Serve as regulatory subject matter expert for Canadian regulatory requirements and compliance-related activities.
• Prepare CNSC compliance reports and support organizational compliance with radiation safety and Transportation of Dangerous Goods regulations.
• Product Portfolio Supported
• In Vitro Diagnostic (IVD) Devices
• Clinical Diagnostic Instruments
• Automated Laboratory Analyzers
• Point-of-Care Testing Devices
• Reagents, Calibrators, Controls, and Accessories

Regulatory Affairs Specialist - Roche - Canada

(2023-02 - 2024-04)

• Compiled, reviewed, and managed electronic regulatory submission dossiers for Canadian diagnostic and medical device submissions to Health Canada, including Clinical Trial Applications (CTA) and amendments, in compliance with HC eCTD requirements.
• Responded to regulatory deficiency requests and managed post-approval changes, working cross-functionally with product development, technical, quality, and operations teams to resolve issues and maintain approvals.
• Maintained accurate records and ISO certificates within Veeva Vault and electronic document management systems, improving traceability and submission readiness.
• Monitored evolving Canadian regulatory requirements and assessed their impact, informing compliant decision-making and regulatory strategy.
• Supported the development and maintenance of Canadian SOP’s and regulatory documentation, standardizing processes across teams.

Regulatory Specialist - Mettler-Toledo International, Inc. - Canada

(2018-08 - 2021-08)

• Established and maintained processes ensuring compliance with Health Canada and FDA requirements, serving as a subject-matter expert and regulatory advisor to internal business units.
• Reviewed product claims and label artwork to confirm regulatory compliance before print and batch release, preventing non-compliant labeling from reaching market.
• Supported ISO 9001, 17025, 13485 certification and recertification of the medical device Quality Management System, contributing to successful audit outcomes.
• Participated in Health Canada GMP inspections and annual self-inspections, driving corrective and preventive actions (CAPA) to closure.
• Reviewed and updated SOPs and standard forms, improving consistency and audit readiness across regulatory operations.

Quality Assurance Specialist - Continental Kosher Butchers Pty Ltd - Australia

(2014-04 - 2018-03)

• Maintained food safety compliance under the HACCP system required by FSANZ, identifying and controlling hazards across receiving, manufacturing, and handling.
• Conducted environmental monitoring and produced monthly compliance reports, supporting continuous regulatory adherence.
• Collaborated with cross-functional teams to create and update SOPs and SDS sheets and resolved customer complaints to maintain quality standards.

Postgraduate Diploma - Regulatory Affairs - AAPS (Academy of Applied Pharmaceutical Sciences), Canada

Master - Biotechnology - Deakin University, Australia

Bachelor - Pharmacy - Acharya Nagarjuna University, India