Purpose of the Role:  Responsible for quality assurance & Regulatory affairs in regards to  Medical devices (Diagnostic Imaging)

Educational Qualification: Preferred- MBA, Essential-  M. Pharm/B. Pharm

Functional/Technical Expertise Required: Technical experience in Quality Assurance & regulatory Affairs, Communication skill both verbal and written business communication, Presentation skills,  Innovative thinking and Fresh ideas, Working in teams, Quick learner,  Flexible, Need to take initiative, self-driven.

Relevant Experience Required: 3-5 years

Role & Responsibilities

Key Deliverables for this position

  • Responsible for compliance to the assigned functions as per requirement of ISO 13485:2016, Indian medical device rules and other QMS requirements.
  • Responsible for independently handling assigned QMS functions
  • Guide the team in development of QMS procedures and forms.
  • Providing independent support to maintain compliance with Regulatory Requirements and International Standards.
  • Decision maker for regulatory planning & regulatory submission.
  • Responsible for documentation, review / approval of Design Dossier prior to submission for Local product registration.
  • Understand the Manufacturing/Factory license requirements and comply with all processes to timely acquire the licenses.
  • Understand AERB, NABL and other guidelines in-depth to facilitate approval process
  • Manage the site internal audit program, manage and host external audits, corporate audits and executing a site-specific audit readiness program.
  • Responsible for review of various new product registration or new process related document and records.
  • Demonstrated ability to effectively work with others in various coordinate disciplines and functional teams, external consultants.
  • Visit Manufacturing facility on regular basis to ensure Quality and Regulatory compliant operations and visit to regulatory authorities as per the requirement.
  • Demonstrated ability to prioritize tasks in a deadline-driven environment.

Key Performance Indicators

  • Responsible for QA & applicable regulatory compliance for Medical devices.
  • Responsible for Regulatory affairs in connection with medical devices.
  • Getting the applicable licenses for refurbished devices & facility.
  • Support on advocacy on regulation for Healthcare business & ensuring adherence to compliances including ISO- 13485

Apply Now

    Please note - Blue Star E&E & its recruitment associates do not charge any applicant / candidate - any monetary or non-monetary return for evaluation or consideration of their candidature.