Talent.com
This job offer is not available in your country.
Dozee - Specialist - Regulatory Affairs

Dozee - Specialist - Regulatory Affairs

DozeeBangalore, India
30+ days ago
Job description

Overview :

  • Include dossier preparation, on-time tracking of applications and network with regulatory bodies and bring in compliance.
  • Play an active role in a change environment.
  • Supports the ongoing implementation and sustainment of Quality and Regulatory compliance as per local and international rules and regulations.

Responsibilities :

  • Plan, establish and maintain a Quality Management System in accordance with EN ISO 13485.
  • Implement regulatory strategies for maintaining compliance with established standards like IEC 60601, IEC 62304, US FDA and CE Marking, etc.
  • Prepares dossiers and device master files for regulatory submissions.
  • Follow the Medical Device Act by CDSCO and other relevant regulations related to products developed and provide directions for compliance to the organization.
  • Work with different teams to setup Quality policies and standards.
  • Ensuring all established quality and delivery commitments are met such as working within FDA regulations, Design Control and ISO Standards.
  • Training and ensuring all assigned employees are aware of and comply with company policies, government procedures, and regulations.
  • Working closely with product development and product transfer teams.
  • Supplier Audit and Qualification.
  • Assist with Management Review meetings including generation of quality metrics and coordinating the review.
  • Provides expertise and guidance in interpreting policies, regulatory and / or governmental regulations, and internal procedures to assure compliance for QMS.
  • Lead audit and inspection preparation, resolution of audit and inspection findings with relevant stakeholders through all stages of the audits.
  • Coordinate CAPA's meetings and provide assistance to the corrective action owners to ensure effectiveness.
  • Ensure employee training compliance to Corporate and site-level QMS.
  • May be responsible for preparing and facilitating quality related training programs for employees.

    • Requirements : .

  • Educational Qualification - B.Tech.
  • Minimum 3-5 years of experience in Medical Device Regulation.
  • Experience with international medical device regulatory approvals and submissions.
  • Experience supporting regulatory agency inspections and Notified Body Audits in an SME role.
  • Demonstrated knowledge of US FDA, EU MDR, ISO 13485 Quality Management System and ISO 14971 Risk Management for Medical Devices as well as IEC 62304.
  • Ability to analyze and interpret standards, technical procedures, professional journals and governmental guidance and regulation documents.
  • Proven experience in new medical device registrations and filings.
  • Working experience with CDSCO, Notified body and other associations for medical device regulation.
  • Able to constructively collaborate with cross-functional teams.
  • Working knowledge of quality assurance methodologies.
  • Knowledge of commonly-used concepts, practices, and procedures for a full product development life-cycle and Medical Device Quality Management System.
  • Support compliance assessments to ensure quality and regulatory requirements are successfully implemented and maintained.
  • Providing guidance to the team to interpret regulatory requirements for various life-cycle stages of the project.
  • Drive Good Documentation practices.
  • Ability to follow instructions, work independently, or function in a team as needed.
  • Highly organized, process orientated and adherence to standard process.
  • Exhibit good leadership across departments and teams.
  • Good time management and project management.
  • Collaborative and a team player.
  • Good interpersonal, listening and communication skill.

    • ref : iimjobs.com)