Team Member – RA Medical Devices Job Vacancy in Cipla Mumbai, Maharashtra – Updated today

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Full Details :
Company Name : Cipla
Location : Mumbai, Maharashtra
Position :

Job Description : Division
Department
Sub Department 1
Employment Type
Job Purpose

Provide all regulatory requirement to R&D teams as Device Regulatory partner for all Combination Products and Devices to guide on US-FDA / EU-MDR pertaining to device constituent part in combination products & standalone device regulatory requirements for device approval in target countries. Collaborate within Regulatory Affairs team and work with Respi, CDT & Regional regulatory teams on compiling/reviewing dossier sections pertaining to combination products and devices as per requirements/procedures/guidelines within the specified timelines.

Key Accountabilities (1/5)

Accountability Cluster:
Provide support R&D teams (Device team and F&D teams) on regulatory requirements for device constituent part in combination products and device regulatory aspects.
Major Activities / Tasks:
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
Key Accountabilities (2/5)

Accountability Cluster:
Support Respi, CDT & Regional Regulatory teams
Major Activities / Tasks:
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
Key Accountabilities (3/5)

Accountability Cluster:
Act as Point of Contact for Device Regulatory aspects within the Regulatory team
Major Activities / Tasks:
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.
Key Accountabilities (4/5)

Accountability Cluster:
Support cross-functional teams
Major Activities / Tasks:
Provide on-going support to project teams for combination product & device regulatory issues and questions
Be a part of project team across the entire device design & development cycle.Provide inputs and adhere to compliance on changes in the regulatory intelligence / competitor intelligence to the Regulatory Intelligence team
Key Accountabilities (5/5)

Accountability Cluster:
Support CQA & Manufacturing teams during inspection of combination products or devices
Major Activities / Tasks:
Ensure availability of all design development documents are available at the manufacturing unit during inspections & provide support in answering any queries related to device development

Major Challenges
Co-ordination with various R&D teams & other internal stakeholders and making sure all device constituent part related regulatory documentation is generated as per regulatory requirement in a timely manner & escalation, if required.
Regular communication/discussions with various RA teams w.r.t challenges faced by them in complying to the regulatory documentation requirements as per combination product regulation/guideline or device regulation/guidelines, resolve & facilitate/support in completion of tasks.
Key Interactions (1/2)

Internal:
Various R&D teams – regularly, weekly/need basis, follow up for required data for ensuring regulatory requirements are met
RA-CDT & Regional RA teams – regularly / need basis, follow up for required data for monitoring compliance
Project Management – regularly / need basis, follow-up on progress of device development and related documentation
CQA / Manufacturing – need basis, for preparation of audits / during inspection
Unit QA / Unit personnel – need basis, for preparation of audits / during inspection
PV – need basis, for device related safety / PV information
Key Interactions (2/2)

External:
Regulatory consultants- to seek advice on the regulatory requirements on unclear guidance’s, new product development strategy (need basis)
Device Development partners, device/component suppliers, device manufacturers: monthly / need basis
Regulatory agencies- for scientific advice and regulatory update status (weekly)
Dimensions (1/2)
Approx. 5+ Nos of combination product filings annually; 10+ device/IVD filings annually
Dimensions (2/2)
Key Decisions (1/2)

Decisions:
Filing strategy
Defining regulatory strategy
Key Decisions (2/2)

Recommendations:
Ensure regulatory compliance
For new product regulatory strategy
Education Qualification

Post-graduate in Science / Pharmacy

Relevant Work Experience

2-4 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.

Competencies

This post is listed Under  Technology
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