Commercial Quality Sr. Specialist

LivaNova (Tokyo, 日本) フォロー 2時間前

Full-time Social Security Regulatory Affairs Data Protection BIA Quality Management System

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Position Summary -

The country Commercial Quality Specialist is part of the commercial organization. The main activities of this position are:
a. Designated Safety Manager for LivaNova Japan, in accordance with applicable regulations of GVP (Good Vigilance Practices) ordinance 135 of PMDA Act.
b. Take initiatives on timely and effective implementation of any Field Safety Corrective Actions.
c. 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.
d. Respond timely and effectively to any local internal or external audit findings coordinating with the Business Units (BU) as applicable.
e. Maintenance of local compliance and applicable regulatory requirements.
For these activities, the position reports to Sr. Manager Regulatory Affairs and Commercial Quality, LN Japan and will receive training and instructions from the Commercial Quality organization and will advise, inform and work collaboratively with the local commercial organization, commercial quality team as well as global customer quality from respective BUs

Job Functions -

Complaint Reporting
a. Assures regions report within one working day, after translation if required, and according to relevant BU's requirements
b. Coordinates obtaining necessary information between customers, sales representatives and Customer Quality
c. Supports, if required, the return of devices for analysis, following BU's requirements and company processes
Field Safety Corrective Actions
a. Works with Customer Quality, Quality Engineering and Materials to obtain customer traceability list for the country/region, if required.
b. Proactively communicate with customers, if required, as per the timelines provided by the relevant BUs.
c. Informs the sales organization of the FSCA and addresses or forwards questions to Customer Quality.
d. Where applicable, is the contact point for the country's health authority for questions regarding FSCA or Post Market Surveillance
e. Report all the applicable field action to PMDA and relevant authorities as applicable.
Compliance to Quality Management System
a. Develops, when necessary local procedures or work instructions to comply with local regulations that do not conflict LivaNova's quality management system.
b. Ensures compliance with applicable regulatory requirements including Ordinance 169, 145, internal GMP guidelines and deployment of any change to LivaNova commercial entities and distributor partners.
c. Maintains the QMS and assist each function to set up related operationa processes.
d. Coordinates and follows up CAPA implementation (s) as applicable.
e. Assures compliance of distribution centers: plan and coordinate external & internal periodic audits, including distributors and supplier evaluations.
f. Tracks the audit/inspection findings and relevant corrective actions for area, Safety Manager is responsible.
g. Collects, analyzes and tracks relevant quality data
h. Supports annual internal audit or other audits as directed by LivaNova’s Internal Audit Program, if needed.
i. Performs other related duties as assigned by management.
j. Ensures compliance to data protection rules.
Compliance to Local Regulations
a. Informs regulatory affairs in BUs of any difference between local regulations and LivaNova Quality system.
b. Handle inquiries from PMDA and third party certification authorities.
c. GVP Ordinance 145 (Revises GVP manuals and generate various official documents, Creates collection work processes, Works on safety management related information).

Requirements -

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 verval 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.
At least bachelor's degree (preferably, in technology or natural science field)
More than 5 years of experience working in a regulated industry within the Quality organization and at least 5 years of experience at Safety Divison in a Medical Device Company (dealing or manufacturing devices with Class 3 or higher) in accordane with local GVP regulations.
Expert in complaint handling (including relevant field actions, such as product recall), adverse event reportability assesment and reporting to competent authorities in Japan.

Our commitment to Diversity & Inclusion:

LivaNova values equality and celebrates diversity. We are committed to ensuring that our recruitment process is fair, transparent and free from unlawful discrimination.

Our selection process is driven by the key demands/requirements for the role rather than bias or discrimination on the basis of a candidate’s sex, gender identity, age, marital status, veteran status, non-job-related disability/handicap or medical condition, family status, sexual orientation, religion, color, ethnicity, race or any other legally protected classification.

Notice to third party agencies:

Please note that we do not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Recruitment Services Agreement, we will not consider, or agree to, payment of any referral compensation or recruiter fee. In the event that a recruiter or agency submits a resume or candidate without a previously signed agreement, we explicitly reserve the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency.

Beware of Job Scams:

Please beware of potentially fraudulent job postings or suspicious recruiting activity by persons posing as LivaNova recruiters or employees. The scammers may attempt to solicit confidential, personal information, such as a social security number, or your financial information. LivaNova will never ask for fees prior/during/after the application process, nor will we ask for banking details or personal financial information in return for the assurance of employment. If you are concerned that an offer of employment might be a scam or that the recruiter is not legitimate, please verify by searching for “See Open Jobs” on https://www.livanova.com/en-us/careers, and check that all recruitment emails come from an @livanova.com email address.