As a global medtech company, we are driven by our Vision of changing the trajectory of lives for a new day and our Mission to create ingenious solutions that ignite patient turnarounds. Our relentless commitment to patients and strong legacy of innovation in healthcare are the foundation of our future. If you're looking for a new chance, a new beginning, a new trajectory, LivaNova is where your talent can truly thrive. Join our talented team members worldwide to become a pioneer of tomorrow—because at LivaNova,
we don't just treat conditions — we aspire to alter the course of lives.
Position Summary
The country Commercial Quality Specialist is part of the commercial organization. The main activities of this position are:
- Designated Safety Manager for LivaNova Japan, in accordance with applicable regulations of GVP (Good Vigilance Practices) ordinance
- 135 of PMDA Act.
- Take initiatives on timely and effective implementation of any Field Safety Corrective Actions.
- Conduct timely and efective reporting of complaints, handling, reviewing and submitting foreign adverse event reports to PMDA on timely
- manner as prescribed in GVP ordinance 135.
- Respond timely and effectively to any local internal or external audit findings coordinating with the Therapeutic Areas (TA) as applicable.
- Maintenance of local compliance and applicable regulatory requirements
For these activities, the position reports to his/her manager and will receive training and instructions from the Commercial Quality organization and will advise, inform and work collaboratively with the local commercial organization.
Essential Job Functions
Complaint Reporting
- Assures regions report within one working day, after translation if required, and according to relevant Therapuetic Area requirements
- Coordinates obtaining necessary infromation between customers, sales representatives and Customer Quality
- Supports, if required, the return of devices for analysis, following TA requirements and company processes
Field Safety Corrective Actions
- Works with Customer Quality, Quality Engineering and Materials to obtain customer traceability list for the country/region, if required.
- Proactively communicate with customers, if required, as per the timelines provided by the relevant TAs.
- Informs the sales organization of the FSCA and addresses or forwards questions to Customer Quality.
- Where applicable, is the contact point for the country's health authority for questions regarding FSCA or Post Market Surveillance
- Report all the applicable field action to PMDA and relevant authorities as applicable.
Compliance to Quality Management System
- Develops, when necessary local procedures or work instructions to comply with local regulations that do not conflict LivaNova's quality management system.
- Ensures compliance with applicable regulatory requirements including Ordinance 169, 145, internal GMP guidelines and deployment or any change to LivaNova commercial entities and distributor partners.
- Maintains the QMS and assist each function to set up related operationa processes.
- Coordinates and follows up CAPA implementation (s) as applicable.
- Assures compliance of distribution centers: plan and coordinate external & internal periodic audits, including distributors and supplier evaluations.
- Tracks the audit/inspection findings and relevant corrective actions for area, Safety Manager is responsible.
- Collects, analyzes and tracks relevant quality data
- Supports annual internal audit or other audits as directed by LivaNova's Internal Audit Program, if needed.
- Performs other related duties as assigned by management.
- Ensures compliance to data protection rules.
Compliance to Local Regulations
- Informs regulatory affairs in TAs of any difference between local regulations and LivaNova Quality system.
- Handle inquiries from PMDA and third party certification authorities.
- GVP Ordinance 145 (Revises GVP manuals and generate various official documents, Creates collection work processes, Works on safety management related information).
Knowledge, Skills And Abilities Required
- Familiarity with Medical Device regulations in Japan, including Ordinance 169 (QMS requirements), 145 (GVP), and PMD Act.
- Fluency in business level English communication both in verbal and writing manner (TOEIC Score: more than 840).
- Proficiency in MS applications (Word, Excel, Power Point, etc.)
- Basic understanding of natural sciense (e.g. physics, chemistry, biology, etc.) and technologies
- Well matured communication skills, such as logical/critical thinking and negotiation with competent authorities (PMDA/TMG/MHLW), and team-work mindset in both internal and external teams.
Education
- At least bachelor's degree (preferrably, in technology or natural science field)
Experience
- At least 5 years of experience in quality assurance and complaint handling (including reporting to competent authorities) in medical device industries with class 3 devices or higher
- More than 5 times of experience in product recalls and field actions thereof.
Welcome to impact. Welcome to innovation. Welcome to your new life.
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