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55 Cipla Jobs

Cipla | Group Leader - Medical Devices - Regulatory Affairs

10-20 years

Mumbai

1 vacancy

Cipla | Group Leader - Medical Devices - Regulatory Affairs

Cipla

posted 21d ago

Job Role Insights

Flexible timing

Job Description


Responsibilities:

  • Support R&D teams during Design Control activities of device constituent part in combination products through preparing of design input (creation of URS considering all product-specific regulatory requirements), design output documents, risk management, design verification (ensure all aspects of verification requirements as per regulatory expectation is covered for combination product/ devices) and validation plans & reports (Ensure design, documentation and regulatory filing requirements are fully compliant to all Threshold Analysis, Human Factors and usability engineering related guidance and standards)
  • Support R&D teams in compilation and perform preparing of technical file/design history file/design dossier documents against regulatory requirements
  • Support R&D teams in validating necessary documentation requirements during design transfer to device manufacturing facility, as per regulatory requirements
  • Work with R&D and cross-functional teams to evaluate proposed device design changes for regulatory impact and to suggest developing necessary documentation
  • Intimate/escalate any delays in device design control activities to manager on monthly basis
  • Support Respi, CDT team in preparing dossier sections for combination products involving device constituent part and devices by providing relevant inputs as per requirements/procedures/guidelines and preparinging relevant sections within the specified timelines
  • Support Regional Regulatory teams in applying and obtaining approval for registration for combination products involving device constituent part and devices

  • Maintenance of global registration/approval database and archive licenses for stand-alone devices worldwide
  • Keep abreast on current device and combination product related global directives, harmonized standards and procedures and communicates changes that may affect cross functional areas.
  • Upkeep of appropriate regulatory documentation related to devices and combination products involving device constituent part are created and properly maintained (e.g. Project Design & Development Plan, Risk Management, design input, design output, design verification, design validation, design transfer).
  • Provide device regulatory support to currently marketed devices.
  • Maintenance of Device Regulatory files to support compliance with regulatory requirements.

Relevant experience:

10 years of experience in the Filing Drug Device Combination product / standalone medical devices. Have independently handled registration and post registration activities including life cycle management and regulatory compliance activities.




Employment Type: Full Time, Permanent

Read full job description

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Top Cipla Regulatory Affairs Interview Questions

Q1. How many packaging lines are you monitoring, describe in detail along with team size & organogram with your position?
Q2. What is hplc and principle Difference between Disintegration and Dissolution Criteria of Dissolution Cu test and Assay test Alcohol plus Hpl ... read more
Q3. concrete properties during concreting how to to check?
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What people at Cipla are saying

Regulatory Affairs salary at Cipla

reported by 4 employees with 5-10 years exp.
₹5.3 L/yr - ₹12 L/yr
52% more than the average Regulatory Affairs Salary in India
View more details

What Cipla employees are saying about work life

based on 7k employees
56%
38%
39%
96%
Flexible timing
Alternate Saturday off
Within city
Day Shift
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Cipla Benefits

Submitted by Company
Child care
Soft Skill Training
Health Insurance
Job Training
Submitted by Employees
Health Insurance
Job Training
Soft Skill Training
Free Transport
Education Assistance
Free Food +6 more
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Cipla Mumbai Office Location

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Mumbai Office
Headquarter
Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai Mumbai
400013

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