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Abiomed
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Assistant Manager- Regulatory Affairs

Assistant Manager- Regulatory Affairs

Abiomed

8 - 12 years

7 - 12 Lacs

Gurugram

Posted:1 day ago| Platform:

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Skills Required

Medical devices ISO 13485 Compliance QMS Business planning Healthcare Management Pharmacovigilance Regulatory affairs Assistant Manager Regulatory Affairs

Work Mode

Work from Office

Job Type

Full Time

Job Description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at

Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Affairs

Job Category:

Professional

All Job Posting Locations:

Gurgaon, Haryana, India

Job Description:

Required Qualification and Core Competencies for the role:

8-12 years of experience in regulatory affairs in medical device industry.
Strong knowledge of Medical Device Rule 2017
Strong knowledge of Drugs and Cosmetics Act
Knowledge in the international regulations of Medical Devices in US and EU
Sound knowledge on Medical Device Quality Management System ISO 13485
Excellent proficiency with software tools

Key responsibilities:

Draft, review and submission of Regulatory filings (Re-registrations/ New Registrations/ Legal-Physical manufacturer transfer).

Draft, review and submission of other Regulatory submissions (Query responses, Corrections fillings, miscellaneous notifications regarding post registration regulatory lifecycle management) for India and IB market in accordance with applicable regulations and relevant guidelines.

Draft cover letters for Regulatory communications/ submissions depending on level of regulatory knowledge/expertise

Update and live maintenance of business plan in SharePoint for assigned franchises/ licenses.

Assist in the preparation of technical presentations/ meetings with regulator

Ensures compliance with regulatory agency regulations and interpretations.

Gathers and assembles information, prepares documents for New Product Applications/Renewal Applications/Change Notifications/Response to Regulatory Agencies questions in accordance with regulations and relevant guidelines

Maintain the changes to the Regulations/Products/Sites and make necessary submission to maintain compliance to Country Regulations (Lifecycle management)

Coordination with internal stakeholders ensuring compliant lifecycle management of responsible products/ franchises.

Maintain the changes to the Regulations/Products/Sites and make necessary submission to maintain compliance to Country Regulations

Attend applicable training sessions as well as complete mandatory on-line e University trainings and submit training records to the supervisor / Admin assistant and work as per the applicable SOPs and guidelines.

Maintenance of RA database for the responsible franchises in MDRIM tool.

Ensuring timely completion of received change assessment within due timeline and provide feedback to source RA team through email/other portals.

Ensuring timely completion of assigned Quality issues/ Corrective Actions in ETS system.

Creation and maintenance of Product Registrations request Form (PRRF) for any registration activities under responsible franchises/ licenses and Change Controls for any product discontinuation/ changes as per defined procedure.

Ensuring timely completion of received change assessment within due timeline and provide feedback to source RA team through email/ other portal.

Ensure on time archival of regulatory submission documents.

Supporting Pharmacovigilance and artwork activities for biological products (if applicable)

Control of regulated/ non-regulated products/ codes in RA gateway tool.

Support with on-time inputs for monthly regulatory report.

Participate in execution of Field Action (Product Recall, Distribution of Field Safety Alerts, etc.) and complete the assigned tasks in a timely manner

Understand complaint & adverse event reporting responsibility and report such events within 24 hours of becoming aware.

Conducting Regulatory Standard Management monthly meeting and keeping a track on action items identified.

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Assistant Manager- Regulatory Affairs