Deepika Pathak

Home: Ottawa, Canada(Open to Relocation)

Phone: +1-343-***-****

Email: adyag5@r.postjobfree.com

Team Member at Tim Hortons, Canada March 2023-Present

• Excellent Communication skills with customers and team members

• Able to do multi tasking as involved in various tasks at the same time

• Managing cash, working on deliverables for customers

• Overlooked the till and ensured the cash and other transactions are accurate.

• Managed complaints, provided appropriate solution and alternatives within the time limit and follow up to ensure resolution

• Focused on each customer experience and made every interaction meaningful.

• Connected customers to the appropriate team members who can help them to resolve their issues.

• Worked effectively as a team, learned with management’s assistance, and supported co-workers to resolve customer issues.

Labeling and Technical Publication Specialist at Stryker, India Feb 2020-Sep 2022 Experienced in projects based on new Medical Device Regulations and handled all documentation of EU MDR and US FDA from reviewing to routing and approval. Worked as a Specialist and aiming for delivering best result with quality in Regulatory Affairs including Labeling and Collateral documents and their publications. Worked on EU MDR Label printing using multiple Label printing system. Hands on knowledge on InDesign for editing documents. Knowledge on Translation Management. Created AHK(AutoHotKey) for automating label printing and reducing manual efforts. Key Responsibilities :

• Strong EUMDR experience with a medical/surgical device manufacturer

• Printed over 100's of EU MDR products labels using Labeling system like SLS, SAP, Easy Label, Prysim based on regulatory requirements like EU MDR

• Hands on experience on EU MDR and US FDA regulations, full understanding on QMS in compliance of ISO 13485

• Review, Routing, Approval of Quality Management Collateral and Labeling documents in SMACC for EU MDR and US FDA

• Publications of Technical documents like IFU's, Optechs, TLC's, SCS, Etc. on various data repositories

• Managing documents and electronic files(like eIFU's) Career Snapshot

Professional Summary

Skilled professional with background of computer engineering and deep knowledge of medical devices in health care. Skilled in Publication of Technical documents that is Labelling and Collateral documents. Working experience on EU MDR. Review and approval of documents. Creating database and maintenance of the same. Knowledge on SQL. ISO 13485 Certified, ISO 9001:2015. Knowledge on SAP, Power BI. Great customer facing and service experience.

Master’s Degree- Computer Application 2015-2018 GGSIPU University, Delhi Bachelor's Degree – Mathematical Science 2011-2015 Delhi University, Delhi ISO 13485 certified, Document Routing for approval, Technical Publication, Label printing, MS Office- Excel, Word, Powerpoint, SQL Database, InDesign, EU MDR, US FDA, Track Changes form, Administration work, Healthcare system, Power BI, SharePoint, SAP, EasyLabel, Bone Anatomy(Trauma and Extremities), Knowledge of Class II,III,IV Medical Devices, Project Management, Report Writing, Technical Publication, Automation, AHK, Program Management Skills, Regulatory Affairs, QMS, Root Cause Analysis, Documentation, 21CFR, NC and CAPA

Education:

Technical Skills:

Data Analyst at Magicpin, India Mar 2019-Jan 2020

Worked as a Data Analyst in maintaining the database using Advance Excel and MS SQL Technologies. Updating and Insertion of data timely for qualitative publishing of content. Have knowledge on database administration. Technologies used : MS SQL, Advance Excel, Google API Scripts for search operations of data

• Run Google API scripts to gather different categories of data online

• Worked on SharePoint and Power BI for data tracking purpose

• Data Gathering, Data Sanitisation and Data Sorting

• Performed advanced analytical functions, including data modelling and prescriptive analytics

• Maintained collaboration between various departments

• Worked maintaining records and data using Excel and SQL

• Handled regulatory quality documents in reviewing, routing, approval process

• Created and submitted other Regulatory submissions such as query responses, corrections filings, adverse/serious event reporting and miscellaneous/change based on EU MDR and US FDA

• Worked on SharePoint to store data, used Power BI for tracking purpose, created trackers

• Involved in operational planning meetings to anticipate work according to the business demand and contribute to business by securing approvals for under-review applications

• Collaborated with third party vendors for Translation Management for Labeling documents, Collateral documents and Labels

•Provided support in the evaluation of processes, procedures and trial conduct to ensure compliance with regulatory requirements

• Worked closely with all functional groups (Business Development, Quality, R&D, Marketing and Operations) within and outside (manufacturing partners) the company to ensure all regulatory obligations are met.

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