Executive – Regulatory Affairs
Sun Pharma
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Job Description
Company:Â Intuitive
Designation: Post Market Surveillance Clinical Analyst
Location:Â Bengaluru
Introduction
At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.
As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare’s hardest challenges and advance what is possible.
Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.
Job Purpose
The Post Market team at Intuitive works at the intersection of Regulatory and Quality. The team processes complaints including meeting our global regulatory requirements. The post market team works cross-functionally to understand product safety and performance and facilitate the execution of robust resolutions. Functions collaborating with the Post Market Surveillance team include Field Action, Data Analytics, Clinical Engineering, Field Service, Technical Support, Customer Service, Risk Management, Service Operations, and Failure Analysis Engineering.
The Post Market Surveillance team requires a Senior Analyst with clinical experience and expertise in analyzing and processing medical device complaints. Â The position requires excellent verbal and technical writing skills, and passion for the best practices to analyze and process complaints.
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Role & Responsibilities
- Perform the preliminary classification of complaints and escalate complaints that require additional review.
- Interface with Customer Service and hospitals to gather additional information required for complaint investigation, including retrieval of RMA
- Collaborate with internal teams including clinical development engineering, human factors, medical safety office, risk management, engineering, and other departments as needed to provide relevant and critical clinical information related to adverse events.
- Evaluate complaints for global regulatory reporting in accordance with company procedures and Regulatory requirements
- Partner with subject matter experts on various activities related to complaint investigations, escalated field events, or regulatory response letters.
- Complete following up with surgeons and other health care professionals via phone and email
- Review product analysis investigation and determine cause / contribution of event to device
- Accurately select Risk (Hazard, Harms, Severity) and IMDRF codes
- Escalate complaints that require additional review to engineering, medical safety officer, clinical development engineering, etc.
- Evaluate documentation for completeness and consistency and identify additional actions as necessary to close the complaint file.
- Approve final complaint file for closure after all applicable actions are completed.
- Participate in new hire training and continuous Regulatory Compliance training as required.
- Participate in process improvement activities to continuously improve process effectiveness.
- Participate in internal/external audits as necessary representing the Post Market Program.
- Perform other duties as directed.
Reporting to the Supervisor, Regulatory Post Market Surveillance, the Senior Regulatory Post Market Surveillance Clinical Analyst is responsible to:
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Educational Qualification
Qualification and skills:
- Clinical nursing surgical or bronchoscopy preferred.
- Firm understanding of world-wide regulatory reporting requirements for Medical Devices and complaint system and process requirements preferred
- Firm understanding of quality records requirements and how they apply to complaint files.
- Able to make decisions quickly using information at hand and evaluate the need to obtain clarification and direction when necessary.
Required Education, Training, Skills
Education: Undergraduate degree in Nursing or Medical degree.
Experience – 3 + years of experience in medical device field.
Training/Competencies:
Location
Bengaluru
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