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ISO Regulatory Compliance Associate
ISO Regulatory Compliance Associate
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ISO Regulatory Compliance Associate

Human Resources's profile picture
Posted by Human Resources
3 - 5 yrs
₹4L - ₹12L / yr
Bengaluru (Bangalore)
Skills
Regulatory affairs
data privacy
ISO/IEC 27001:2005
ISO 27001
soc2
Quality audit
FDA
samd
eu

Job Title: QA Associate 

 

Job Description:

  1. Responsible for Implementing, controlling and monitoring quality management system documentation (ISO 27001) and data privacy (SOC2).
  2. Coordinate improvement in the system through output from audit, management review, and responsible to close NC’s during audits.
  3. Knowledge of SAMD (Software as Medical Device) SaaS product, processes and procedures.

 

3-5 years of relevant experience in Medical Devices Industry.

 

 

Area of Expertise:

  • To generate, implement and maintain internal quality procedures and systems to comply with ISO 27001, SOC2 standards
  • Maintaining and updating various documents like internal docs log, external log, , Obsolete docs log, DCN, ECN, CAPA, SQA/IQA log, product complaint, equipment log
  • Maintaining Engineering documents like part specs, Bill of materials, Drawings, Design review documents etc
  • Co-ordinate and conduct periodic internal audits of various functional groups of an organization and drive compliance to QMS.
  • Manage all documentation related to internal and external audit.
  • Manage all the documents related to supplier qualification and coordinate Supplier’s audit and maintain the supplier file.
  • Experience in Handling of CAPA (Corrective & Preventive Actions) & Product Complaints
  • Co-ordination of Management Review Meetings & its action items implementation

 

Experience Required:

  • 3-5 years of relevant experience in Medical Devices Industry.
  • Educational Qualification – Diploma/Engineering graduate, preferably Computer Science or related.
  • Ability to read and understand standard requirements independently.
  • Good teamwork, communication and interpersonal skills. A demonstrated commitment to company values
  • Good understanding of design control, and post marketing processes
  • Knowledge of FDA / EU / Indian & other national regulations is an added advantage.
  • Working knowledge of an e-QMS is an added advantage.
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Shubham Vishwakarma

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About Synapsica Technologies Pvt Ltd

Founded :
2017
Type :
Services
Size
Stage :
Raised funding

About

Synapsica is a HealthTech and Teleradiology firm founded by alums from AIIMS Delhi, IIT - KGP & IIM - A with a vision to increase accessibility of diagnostic services to every corner of world. We are developing Artificial Intelligence for Radiodiagnosis to aid radiologists by reducing errors, improving efficiency and automating any monotonous work. Presently, our radiologist and tech panel has some of the best talent from top institutes in the country. We use NLP, Computer Vision & Deep Learning based software products to assist diagnosis in X-Ray, CT and MRI scans. Our Machine Learning automation allows for workflow management at Diagnostic Centers bringing efficiency to the entire process of stakeholders coordination, disease interpretation & report generation. Through our efforts we hope to bring accountability, standardization, efficiency and hence better patient care to the medical field.
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Tech stack

skill iconKubernetes
skill iconAmazon Web Services (AWS)
skill iconDocker
skill iconPython
Firebase
skill iconMongoDB
skill iconReact.js
skill iconNodeJS (Node.js)
skill iconMachine Learning (ML)

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ROLES AND RESPONSIBILITIES:

  • Creating buy-in for the product vision both internally and with key external partners
  • Developing product positioning strategies
  • Translating product strategy into detailed requirements and prototypes
  • Gain a deep understanding of customer experience, identify and fill product gaps and generate new ideas that grow market share, improve customer experience and drive growth
  • Scope and prioritize activities based on business and customer impact
  • Work closely with engineering teams to deliver with quick time-to-market and optimal resources
  • Evaluate promotional plans to ensure that they are consistent with product line strategy and that the message is effectively conveyed
  • Act as a product evangelist to build awareness and understanding
  • Represent the company by visiting customers to solicit feedback on company products and services
  • Design and execute multiple A/B and multivariate tests to optimise conversion across different steps of the acquisition funnel from landing pages to conversion
  • Analyse and track funnel performance
  • use different analytics products to analyse and interpreting trends and provide actionable insights
  • Produce meaningful Funnel KPI dashboards and deliver monthly, cross channel performance reports with actionable insights for product, marketing and business teams
  • Determining the Digital journey of learners.


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●      Bachelors in Computer Science, Mathematics or related work experience

  • Experience in shipping growth products or working in growth teams preferable
  • Excellent problem solving skills with strong ability to break down problems and Strong analytical skills, comfort with handling data sets and deriving insights or building attribution models using the data
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  • Flawless communication skills, the ability to articulate and evangelize product vision, strategy priority and - Go to market plans- in a compelling manner
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Shubham Vishwakarma

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