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Manager - Regulatory Affairs - Medical Devices

3 months ago

New Delhi, India DSS Imagetech Pvt Ltd Full time

About Position:

This is a full-time on-site position for a Regulatory Affairs Manager in New Delhi. The Regulatory Affairs Manager will be responsible for managing the Regulatory Affairs function of the organization and it's group companies and communicating effectively with internal & external stakeholders.


Qualifications

Degree in BPharm / MPharm / Biotech or any Biological Sciences with a strong knowledge and experience of regulatory domain.


Experience:

  • 10+ years experience
  • Good hands on experience of working with the CDSCO Department


Job Description:

  • Plan & develop procedures to ensure regulatory compliance for the organization.
  • Keep up to date with national and international legislation, guidelines and customer practices to ensure that the organization's products comply with the regulations of the region where they want to distribute them.
  • Ensure that the interfaces between Regulatory/Quality and other departments are managed optimally from initial stages of product planning through till securing government approvals..
  • Monitor and set timelines for license application & query submissions, approvals and renewal including fresh applications, renewal applications, ethical committee clearances if required; for predicate devices and non-predicate devices, legal metrology compliance, MRP compliance, voluntary and non-voluntary registrations, medical devices - instruments and IVD kits.
  • Prepare & oversee accurate submission documentations of license applications in collaboration with principal’s regulatory teams and/or dealers/distributors for products to be registered in India or company owned products to be registered across the world.
  • Represent the organization in front of regulatory authorities in the country (CDSCO, DGHS, DAHD, DCA, FSSAI, CPCB etc.) as well as in front of the regulatory team of principals/distributors/dealers.
  • Maintain audit compliance for the organization wherever necessary from a regulatory point of view.
  • Post marketing surveillance reports compliance - sending out Field Safety Corrective Actions to customers and following up on the information, compiling information and sharing with the right stakeholders
  • Evaluate all complaints for potential Reportable Events (pREs).
  • Manage a system for the investigation and appropriate follow up of recalls to inform the Health Authorities.
  • Ensure appropriate reporting in line with Company requirements on Complaints & Adverse Events & Recalls.
  • Optimize, revitalize or set up SOPs for Regulatory function for the Organization.
  • Ensure that the Regulatory department provides a value added function to marketing including working collaboratively on product promotional plans and representative training activities including packaging, labeling and flyers with respect to regulatory compliance.
  • Ensure effective team communication throughout the Regulatory department through the application of suitable reporting systems and structures and the identification and provision of appropriate training.
  • Provide coaching to the Regulatory/Quality Associates in various aspects of management.
  • Have responsibility for the financial management of the regulatory/quality budget.
  • Ensure timely registration of all new products and instruments and obtaining relevant licenses.
  • Educate team members appropriately to ensure accurate understanding of regulatory requirements and compliance to the same at every stage of development.
  • Conduct regular training for the team across divisions to comply with regulatory requirements as per company requirements on Regulatory Domain.
  • Ensure all appropriate specifications and procedures pertaining to products are on file.
  • Notify senior management of any notifications by Health Authorities or Regulatory Body for inspections, visits, permit renewals or licenses. Coordinate such visits and inspections to ensure total compliance.
  • Proactively engage with regulators and health officials and maintain a positive relationship. Educate management on any likely changes in the regulatory environment that may affect business.
  • Be the face of the organization to regulators, participate in appropriate forums and convey the Company's point of view on all relevant matters.
  • Ensure Compliance to QMS requirements.
  • Coordination with Principals
  • Approve POs from Regulatory perspective before the shipment is sent to India
  • Provide the planning and leadership to the Regulatory / Quality department by ensuring that appropriate structures, systems, competencies and values are developed.


Job Requirements:

  • Problem-solving approach,
  • Candidate with high integrity to easily fit in the organization's legacy.
  • Able to work in smaller and larger teams


Desired Skills & Experience:

  • Excellent communication and interpersonal skills
  • Flexibility of working across time-zones considering the availability of principal companies regulatory teams from across the globe.
  • Experience working with cross-functional teams including remote team