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