Rasika Ranade, Ms-Ra Email & Phone Number

Minneapolis, Mn, Us

Mineral Wells, Texas, Us

Edgewood, New York, Us

Bloomfield, New Jersey, Us

•Project Management- Creating and maintaining CE Technical files for new and existing Class I, II devices as per MDD and MDR (2017/745), MDCG and Basic UDI-DI guidelines•Compliance of documents as per ISO 14971, ISO 13485 and other standards•Work cross functionally with R&D, Manufacturing, Sales/Marketing, Quality team, providing regulatory strategy, timelines, and deliverables for sterilization devices and solutions•Prepare US and EU submission, working with FDA, Notified Body, and regulatory geography support to obtain product approval/clearance•Identify needs for device testing. Write, review and approve testing protocols and reports•Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, clarification and follow-up of submissions under review•Review OEM requests for Change Orders and assess proactively research regulatory impact of product changes on US, EU and/or International regulatory strategy and submissions per standard procedures•Review labeling, GUDID, GTIN and assess compliance against relevant regulations and product requirements•Perform Post market activities (PMCF), Clinical Evaluation Reports (CER), recall activities if necessary•Perform receiving, in process, and final quality inspections and continuous improvements of various processes for better efficiency•Supplier Audits, Supplier Corrective Action Requests (SCARs) and Quality inspections•Worked on formulation, testing and FDA submission for Sanitizer and other products for sanitation

Clearwater, Florida, Us

• Regulatory Submissions: Submissions and licenses required by Canada, EU, and US (IDE, Pre-subs, 510(k)). Technical Files, ER, DOC’s, MDD product lists, CER, eCTD, International Regulatory Affairs- Health Authority submissions, ISO• Regulatory Strategy: Developing regulatory and compliance operating procedures and policies, regulatory assessments of device modifications, QSR, Inspections and audits.• Labeling: Application of CAPA’s to labeling, partnering with Translation Coordinator(s), proficiency in domestic and foreign regulations. GTIN numbers and GUDID Registrations. California Prop 65.• Quality Assurance Responsibility: Control documents, DHR, data collection forms, drawings, procedures and specification, SOP’, WI.• Complaint Handling: Performing complaint investigations with R&D, Manufacturing, Sales and Marketing. Assisting in customer defect tracking & resolution of issues. Communicating with OEM customers, distributors and doctors/nurses at user facilities.• Adverse Event, Vigilance Reporting & Field Actions: Complete incident reports, submission of Medical Device Report (MDR) & Vigilance Reports, performing periodic trending, execution of field actions, project management, reporting to regulatory agencies, tracking field action effectiveness, agency status reports, responding to agency inquiries, CAPA.• Post Marketing Surveillance: Investigations of product malfunctions, product design &/or labeling problems & customer issues. Monitoring metrics based on performance trends.• Process Improvement: Working with cross functional team to implement robust solutions for processes/device non-conformances. Feeder system metrics reviews, product enhancements, liaise with R&D and teams to ensure new product readiness for complaint vigilance quality process support.

Boston, Ma, Us

•Under the supervision of Interlibrary Loan Librarian, performing a variety of technical and clerical duties of MCPHS University Interlibrary Loan Department.Using Resources at Countway Library of Medicine, as Interlibrary loan staff, MCPHS.

Boston, Ma, Us

•Responsible for overseeing the library and supervising the student workers.

Boston, Ma, Us

Boston, Ma, Us

• Translating & Transcribing the Pharmacy prescriptions from late 18th and the early 19th century to study the medicines used and pattern of development in prescription writing over the century. •Maintaining the records of the decoded prescription in a database to easily study the prescription with the transcribed version of it.

Teaneck, New Jersey, Us

• Developing and Implementing the regulatory strategy.• Effective communication & coordination with India’s Regulatory Authorities.

Navi Mumbai, Maharashtra, In

-Performed various analytical tests using equipment’s like HPLC, Coulter counter, TLC, Gas Chromatography, Total Organic Carbon, Ultrasonic in In Process Quality Control (IPQC) Department.-Implementing the working and operations of laboratory equipment as per the Standard Operating Procedures.-Hands on experience in good documentation practice, drug validation, and GMP protocols for cleaning.-Oversaw the process of the entire working of the pharmaceutical company including process development, pharmaceutical engineering, supply chain management.

Doctor Of Philosophy - Phd, Business Administration And Management, Healthcare A

Master’S Degree, Pharmacy Administration And Pharmacy Policy And Regulatory Affairs

Bachelor’S Degree, Pharmaceutical Sciences

Education record