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44 Cipla Jobs

Cipla | Group Leader - Medical Devices - Regulatory Affairs

10-20 years

Mumbai

1 vacancy

Cipla | Group Leader - Medical Devices - Regulatory Affairs

Cipla

posted 4d 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?
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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 6.9k 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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