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Dozee

Posted 21 days ago

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Regulatory Affairs Specialist

BangaloreOn-siteFull-time

AI Summary

Lead Regulatory Affairs Specialist at Dozee, driving global regulatory strategy for medical devices and SaMD products, managing submissions and compliance with FDA, EU MDR, and ISO standards, and mentoring a regulatory team.

About this role

Overview: Dozee Health AI is a pioneer in Contactless Remote Patient Monitoring (RPM), proven to drive transformation at scale. Headquartered in Bengaluru, India, Dozee has emerged as India’s no. 1 RPM Company.
We are seeking visionary individuals to help us in this very exciting journey. As a part of our dynamic team, you’ll have the opportunity to collaborate with top healthcare providers in the country, applying AI-powered RPM solutions to tackle some of the most pressing challenges in healthcare - enhancing staff efficiency, improving patient outcomes, and pioneering the next generation of care models.

Role Overview: As a Lead Regulatory Affairs Specialist at Dozee, you will drive global regulatory strategy for our medical devices and SaMD products. You will manage regulatory submissions, ensure compliance with FDA, EU MDR, and international standards, and mentor a growing regulatory team. This role offers the chance to shape the regulatory landscape of innovative healthcare technologies, ensuring safety, efficacy, and timely market access worldwide.

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. Turtle Shell Technologies Private Limited No. 40, City Centre, Chinmaya Mission Hospital Road, Bengaluru (Bangalore) Urban, Karnataka - 560038
  • 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, with good interpersonal, listening and communication skills

    • Skills

    CAPACDSCODesign ControlDevice Master FilesEU MDRFDAGood Documentation PracticesIEC 60601IEC 62304ISO 13485ISO 14971Medical Device RegistrationNotified Body AuditsProduct Development Life CycleQuality Assurance MethodologiesQuality Management SystemRegulatory SubmissionsSupplier Audit And Qualification

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