Medical Device Safety

A passionate, diligent regulatory affairs graduate student with two years of working knowledge and expertise in healthcare, pharmaceutical and medical device domain. Actively seeking full-time opportunity to enhance my skill sets and attain professional growth the field of regulatory affairs.

EDUCATION & PROFESSIONAL DEVELOPMENT

Northeastern University, Boston, MA

Master of Science in Regulatory affairs for Drugs, Biologics and Medical devices.

Relevant Coursework- The FDA Pharmaceutical and medical device regulatory, Therapeutic and medical device development, Fundamentals of clinical trials, Legal issues in International drug and Regulations (EMA), Regulatory submission to Australian, Asian, and Latin American Regulatory strategic planning and project management, Regulatory culture compliance.

December 2020

GPA: 3.7

Bharati Vidyapeeth Dental College and hospital, India

Bachelor of Dental Surgery

December 2016

GPA: 3.0

CORE COMPETENCIES

Two (2) years of working knowledge in the field of medicine, competency in biology, biochemistry, Medicine, clinical/ research study, and healthcare work domain. 1.6 years of working experience in regulatory approvals and submittal experience (EU MDD, Health Canada, USA, etc.)

Working knowledge of GXPs, ICH, FDA, EMA guideline, ECTD,510(k), PMA, IND, NDA, BLA and IVD submissions.

Working knowledge with experience and contribution in the design, development and launch of a medical device.

Ability to effectively compose FDA agency submissions, interface interdepartmentally and complete assignments with minimal supervision with strong written, oral and interpersonal skills

Proficient knowledge of domestic and international standards, working experience with FDA 510(k) submissions

Efficiency to work on technical documentation/findings to a broad audience of varied expertise in a team.

Competent to manage multiple tasks and perform with accuracy and a high attention to detail

Keen interest in learning risk management, design control documents and scientific testing that support a device registration.

Ability to self-direct an independent project and communicate effectively with cross-functional teams to attain project completion. Experience with wireless technology, Knowledge of MDR

Technical Writing: Skilled to prepare regulatory documentation including SOPs, product manuals, Instructions for Use (IFUs), process flows and work instructions.

Proficiency in Excel, PowerPoint, Microsoft word, Outlook, Agile, Microsoft office Suite OneNote, Visio, Adobe Acrobat, Smartsheet Statistics, and graphs.

PROFESSIONAL EXPERIENCE

Organogenesis Inc. January 2020- July 2020

Designed and conducted the planning, preparation, assembly, review and publication of regulatory submissions to the FDA and other worldwide government agencies.

Actively coordinated in compiling and submission of regulatory submissions, including filing and/or creation of Dossiers, Premarket Notifications, Supplements, and Change Notifications.

Represented RA on cross-functional product development and manufacturing support teams. Guide teams to provide content for International submissions, participates in design reviews as needed.

Represented RA team on project teams (Adjustable curette) with members of development project teams as necessary to communicate regulatory submissions requirements and preparations according to a defined timeline.

Effectively participated on Product Development teams, providing regulatory labeling strategy, timelines, and direction.

Articulated product portfolio, leading to a successful completion projects for global project in a cross functional team.

Optimized and Reviewed Change Orders & labeling, manufacturing change and compliance or design changes that impact the product in US and/or International regulatory strategy as per standard operating procedure.

Assisted in a cross functional team for Regulatory submissions by ensuring the are accurate and verifiable source documents to confirm compliance and traceability. Conducted reviews of product and manufacturing changes for compliance with applicable regulations.

Supported and Recommended changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance. Majorly for class III, II, I medical devices and HTCP/s products.

Reviewed and approve product labeling and promotional materials, per company procedures, to assure compliance with regulatory requirements.

Optimized, prepared and reviewed technical documentation. Technical document for medical device product, and regulatory strategies for new and modified products

Recommended changes for labeling, package inserts, approve advertising, promotional items, manufacturing, marketing, and clinical protocol for regulatory compliance and Ensured relevant ISO and FDA Export requirements are met, as required

Efficiently worked in a cross functional teams to deliver supporting documentation (IFU, DHF, CER etc. Prepared and communicated submission/compliance strategy document. Ability to review and approve final product packaging based on compliance with U.S. labeling regulations.

Recommended internal stakeholders (marketing, manufacturing, R&D, etc.) regarding current/pending guidance, regulations, Agency/industry initiatives, etc. To ensure regulatory strategy is in alignment with company objectives.

Updated the regulatory team by providing application progress to internal stakeholders. Supported potential regulatory approvals risks based on changes in regulations, standards country specific issues or other unique characteristics of the project

Communicates changes to global markets and provides submission deliverables. Designed and conducted team training for regulatory team on UDI, Risk benefit assessment, company databases with required information and statuses for licenses, registrations, renewals, products, and other required data.

Medical Device Project- Breegi Scientific INC. June 2019 – August 2019

Articulated regulatory documents templates in support of device submissions to regulatory authorities US FDA/ EU

Developed templates on evaluation of product prototypes, writing of test methods, development and documentation product concepts, of all test results.

Designed a submission plan to support 510(k) and CE marking for Neonatal Incubator under U.S FDA/ EU regulations.

Created a strategic R&D plan focused on biocompatibility, functional safety testing, sterilization, packaging validation.

Attained project goals by reviewing Advertisement and Promotional material, Quality assurance, Safety controls in Regulatory Compliance with other global regulatory requirements and quality standards ISO 13485:2016 / ISO 14971, IEC 60601.

Advocated data collection focused on safety and designed SOP template; standardized prototyping.

Experience in Dentistry

Dentist Dr. Hire’s Dentora oral & Maxillofacial Clinique, India December 2016 – October 2018

Performed four handed dentistry and provided quality services in a safe, efficient, effective, and timely manner meeting all applicable hospital, regulatory, licensure, and accrediting regulations, practical knowledge of appropriate safety regulations.

Interacted with regulatory bodies and maintains regulatory documents, conformity check to hospital standards of performance.

Worked collaboratively in a fast-paced, team-based matrix environment and to function independently as appropriate.

Experience in Regulatory Affairs:

Atlantic Biomed, India Dialyzer Reprocessing System- Medical equipment and supplies June 2008 - August 2009

Worked as a regulatory affair trainee in the Compliance team on data collection, information and reports required for the complete submission to support product registration.

Actively Facilitated and documented cross-functional team meetings to ensure on time delivery of product supply and key program regulatory milestones to develop and maintain program plans.

Ensured tactical program deliverables align to overall program strategy

Optimized clinical supply execution and operational excellence by implementing program management tools like timelines, minutes, agendas, risk management, and best industry practices to ensure delivery of supply and regulatory filings by ensuring compliance.

Designed and provided regulatory support for global regulatory teams on international regulatory requirements. Also Support manufacturing changes for compliance with applicable regulations.

Provide domestic and international regulatory guidance on product development and product label creation. Perform scientific statistical analysis on formulation analytical data.

Manage International registration projects as needed by customers. Ability to communicate with regulatory agencies on administrative and routine matters.

Worked closely with cross-functional teams to plan and develop scope, deliverables, required resources, work plan, budget, and timing for program associate with product launch.

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