Manager – Regulatory Affairs

7 days ago

Delhi, Delhi, India Zoot Systems Full time
Zoot Systems is a New Delhi, India based company. For years, it has been our continuous endeavours to understand Client quality-conscious discerning business needs and to successfully meet those. We specialize in the creation of high-quality I.T./Non-I.T. based HR Solutions, Recruitment, and RPO to companies of all sizes resulting in better, faster, and more meaningful results. With a focus on state-of-the-art I.T. /Non-I.T. services, Zoot Systems developed a niche and expertise in Staffing, IT Recruiting, Non-IT Recruiting, and Offshore Outsourcing services. I have an urgent position with one of my Client; below are the Job Details kindly take a look & let me know your comfort level too. Job Title: Regulatory Affairs (Medical Device) Employment Type – Full time Work Experience – 4-10 Year in a similar role Location – Dwarka (2 mints walk metro station) Job Overview:The individual is responsible for conducting the regulatory projects from End to End perspective, responsible for timely filing of the application, diligent review and communication with Client. This involves expertise w.r.t Indian regulatory system and CDSCO.
Job Responsibilities:
  • The minimum experience we are looking at is 3+ years
  • Preparation of checklist for MD 3, MD 4, MD 7, MD 8, MD 12, MD 26, MD 14, MD 16, MD22, MD26, MD28
  • Application submission for Test License, Manufacturing License, Import License, Permission to import new medical devices
  • Application filing for post-approval changes & post submission change request
  • Providing regulatory guidance to the local business partner.
  • Providing regulatory support for product changes/notifications, labelling, CE marking and promotional material review and approval.
  • Preparation of Device Master File as per MDR 2017.
  • Preparation of Site Master File as per MDR 2017.
  • Preparation of documents and preparation of gap analysis as per the checklist.
  • Responding to queries raised by the client and regulatory body.
  • Maintaining track record for submitted and approved application documentation
  • Preparation and review of draft labels, artworks, IFU for compliance with applicable regulations and standards.
  • Preparation and submission of documents required for clarification NOC from CDSCO.
  • Literature Survey for products safety and efficacy profile and regulatory status
  • Preparation and review of Sugam Registration for submission
  • Preparation of QMS documents [ SOP (All Department), List, Format, Quality Manual, Quality Management System Procedure, SMF, MFR]
  • Preparation of all department SOP/ STP/ STS/ QP.
  • Developed and maintained product verification and testing documentation.
  • Study and review of Stability, Aging, Device life, General safety, Bio Compatibility.

Education:Pharm/M. Pharm from a reputed college Additional Skills Required: Communication: Good in English communication. Should have good conversational skills Interpersonal Skills: Excellent Interpersonal skills. Should be able to work with the team, able to communicate effectively with colleagues and clients. Multi-tasker, highly motivated, organized and detail-oriented individual.
Sameer Manager- Talent Acquisition Zoot Systems Email: dot com (need to put "." instead of "dot")

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