Job Description
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: sameer@zootsys dot com (need to put "." instead of "dot")
Skills: medical devices,federal & state regulatory compliance,communication,regulatory affairs,mdr,class iii medical devices,biomedical devices,medical device r&d
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: sameer@zootsys dot com (need to put "." instead of "dot")
Skills: medical devices,federal & state regulatory compliance,communication,regulatory affairs,mdr,class iii medical devices,biomedical devices,medical device r&d
💡 Quick Summary
Seeking a career-building opportunity? The Manager | Regulatory Affairs |Medical Devices position is now open for candidates interested in the Health Jobs sector. This role in Central Delhi offers a professional environment and growth potential.
Requirement Snapshot: Candidates should possess basic communication skills, a proactive attitude, and the ability to work in a team. Experience in Health Jobs is a plus.
