Health elevated.

Senior QARA Specialist

Inito

Inito

Bengaluru, Karnataka, India
Posted on Wednesday, May 15, 2024

Responsibilities:

  • Develop and implement regulatory strategies for Digital health products, specifically Software as a Medical Device (SaMD) and connected devices.
  • Collaborate with software development teams to align Software Development Life Cycle (SDLC) processes, ensuring regulatory considerations in every phase.
  • Assess the impact of changes in the SDLC on regulatory compliance and provide recommendations for modifications or additional documentation needed.
  • Work closely with the validation team to define and execute software validation activities per regulatory requirements, including developing validation plans, protocols, and reports.
  • Handle QMS activities wherever required including, but not limited to, Change Requests (CR) and Corrective and Preventive Action (CAPA) cases.
  • Review technical documentation, protocols, and reports, assessing their appropriateness for specific regulatory purposes.
  • Actively participate in core groups (development, production, launch coordination, product maintenance), and other stakeholder teams.
  • Develop regulatory submissions strategy for the product portfolio, offering guidance to cross-functional teams.
  • Integrate regulatory perspectives into risk management processes, identifying, assessing, and mitigating risks associated with software development in alignment with ISO 13485, ISO 14971, and other relevant standards.
  • Collaborate with the customer success team to appropriately document, investigate, and report software-related issues and updates in compliance with regulatory requirements.
  • Coach and mentor junior colleagues within the team.

Note: Only shortlisted candidates will be contacted