Shruti Gangwal

Responsible for implementing global regulatory roadmaps by understanding the competitive marketing strategy.  Advice product design teams on regulatory strategy and requirements for specific new product/solutions.  Responsible for regulatory planning for new product introductions (Global) and product changes, and assist in maintaining regulatory compliance.  Provide guidance on regulatory risk assessment, required corrective actions to meet regulatory requirements.  Develop and facilitate regulatory submission for new product solutions/existing product solutions.(CE,510(k),MDR transition,supporting other country registrations)  Review and validate marketing and labelling materials.

 Ensured compliance to worldwide regulatory requirements for complaint handling.  Processed complaints and reviewed for adverse event trends.  Submitted adverse event reports to health authorities.  Handled post-Market Risk Assessment activities.  Undertook trending of product complaint data for management review.  Supported regulatory team and Quality team with Ad-Hoc regulatory project/quality assignments.

•Responsible for registration of medical devices in EU (CE, technical file) and Canada (Class II,III) & supported USFDA (510(k)) Japan, Korea & ASEAN regulatory submissions. •Planned and implemented regulatory strategies and created project management plans for new projects. •Authored regulatory plans and product labelling requirements. •Interfaced and coordinated with regulatory agencies/notified bodies on submissions, approvals, audits or other issues. •Handled complete regulatory compliance from product concept to commercialization (New product development process) •Developed local Regulatory process and procedures in accordance with various standards and regulatory requirements. •Pioneered high impact RA projects at global level by collaborating with Stryker worldwide regulatory teams and established the regulatory assessment process for Global Manufacturing Transfer projects. •Developed Regulatory SharePoint Site for the company which was a one stop solution for all the Regulatory insights and tools to enhance speed to market for medical devices in various countries. •Trained R&D, Supply Chain, Marketing and Sales teams on basics of regulatory affairs, standards & labelling for medical devices and acting as internal auditor as per ISO 13485 for these functions.

•Managed documentation per established product documentation, records management policies and produced as required for litigation/product history reviews/ISO audits/FDA/etc. •Monitored the change control processes to ensure timely review, release and implementation of documents. •Provided documentation support for national and international product introduction and registrations. •Supervised corporate data entry activities ensuring that all the trend data, charts, reports are posted and provided timely. •Partnered with field document control to review, update, control and maintain all Quality System documentation for Corporate Management review.

•Performed triaging of incoming Adverse Event Reports for initial assessment of seriousness, expectedness, causality, and reportability for reports from clinical trials and post marketing sources in accordance with local work instructions, sponsor specific Standard Operating Procedures, US FDA regulations, and international guidelines and regulations. •Ensured adherence of the department with sponsor-specific Standard Operating Procedures and FDA requirements for audit procedures pertaining to SAE's. •Assisted in assembling data to support FDA filing.

Regulatory Documentation: •Conceptualized and developed effective document collection and retention system for regulatory documents for the compilation of dossier for Supplemental New Drug Application (sNDA),New Drug Application (NDA). •Worked on IVRS, IWRS, Inform, CTMS. QA: •Planned, scheduled and conducted internal audit in compliance with GCP, regulatory requirements and internal procedures.Communicated audit results to management and auditees through written audit reports. •Evaluated potentially critical problems not covered by policies, standards, and regulations; developed CAPA plans relating to quality and compliance issues and appropriately escalated any compliance issues.

Gained experience in GMP and related documentation-Batch Manufacturing Records, Master Records and Deviation Forms. Performed compilation of personnel SOP-training files to be submitted to the Quality Assurance department prior to an audit and managed SOP training database.

Course work: New Drug Development: QA and Regulatory Overview Biologics Development: QA and Regulatory Overview Medical devices Development: QA and Regulatory Overview Human Experimentation: Methodological Issues Fundamental to Clinical Trials European Compliance Process and Regulatory Affairs Practical Aspects of Regulatory Compliance International Clinical Trials Food,Drug and Medical Device Law