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

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.
• 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.
• 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.

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.

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.

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