QA RA Specialist France

Department Info

Terumo Quality, Regulatory & Vigilance Division provides supporting services in quality, regulatory affairs and post market surveillance to Terumo internal and external customers on an EMEA basis.

Job Summary

As QARA specialist you are in charge of applying and implementing the follow-up of the Terumo Europe Quality system, as far as applicable to Terumo France, in accordance with the objectives and policies set out by Terumo Europe. In this role you report to the Quality Systems Manager, Bert Pipeleers. 

The QARA specialist is in charge of handling the contacts with Terumo Europe RA in order to obtain and manage the EC declarations of conformity for all products, the ISO certifications of all factories and all of the declarations needed to meet the requests of the database of the Ministry of Health, ANSM and tender department.
The QA/RA specialist supervises the complaint handling process for Terumo France and supervises the QARA assistant (TBH). 
 

Job Responsibilities

Complaints & Vigilance
•    Safety Notifications & Product Recalls: Implement and follow through on safety notifications, product recalls, and any corrective or preventive actions related to complaints or product non-conformities.
•    Complaint Handling: Initiate and manage the complaint handling process for customer complaints reported from Terumo France markets.
•    Trend Analysis: Analyze KPIs and other trends related to customer complaints (PPR).
•    Alerts: Notify the Terumo Europe team of unfavorable complaint trends or serious patient injuries.
•    Training: Inform and train Terumo France personnel on complaints and regulatory affairs.
•    Regulatory Communication: Liaise with the Ministry of Health or ANSM regarding post-market monitoring activities and healthcare advertising.

Regulatory Affairs
•    Legislation Compliance: Monitor and ensure compliance with applicable legislation for medical devices distributed in France and Monaco.
•    Future Trends: Stay informed about future trends in European and French medical device legislation, participate in discussions, and influence when necessary (e.g., through SNITEM).
•    Organizational Updates: Keep the Terumo organization informed on national legislation, including decrees and guidance from French and other relevant competent authorities.
•    Promotional Material Review: Revise local promotional materials for regulatory compliance.
•    Customer Requests: Respond to various customer requests (e.g., product-related questionnaires, specific statements).
•    Mandatory Statements & Notifications: Prepare mandatory statements and notifications to the ANSM, including the declaration of activity and communication of devices for France and Monaco.
•    Authorization Requests: Submit authorization requests to the ANSM for local promotional materials.
•    Reimbursement Support: Assist in the preparation and submission of national reimbursement files.

Quality Management System
•    QMS Maintenance: Maintain the quality management system in Terumo France, ensuring compliance and alignment with Terumo Europe’s QMS and any additional local requirements.
•    Procedures Management: Create, review, and update local procedures.
•    SOP Management: Oversee the local SOP approval and distribution process through SmartSolve, monitor the validity of local SOPs, and ensure timely revisions.
•    Audits Participation: Participate in internal quality audits and those conducted by notified bodies or customers.
•    KPI Analysis: Analyze quality indicators and KPIs, and report follow-up results to the Management Team (MT) regularly.
•    Training: Provide comprehensive training on the Quality System and internal procedures to the TF organization.
•    Regulatory Implementation: Contribute to the implementation of new Medical Device Regulations where applicable.

QA/RA Team Leadership
•    Supervision: Supervise the QARA Assistant in TF and lead your team effectively.

Profile Description

• Master degree
• Min. 5 years’ experience in a similar QARA specialist role
• Interpersonal skills and work effectively in a cross-functional team
• Native French speaker and good knowledge of English (written and spoken)
• Understanding of the EN ISO 13485 regulations, as well as of the Medical Device Regulations (and its national transposition in France/Monaco) and their applicability within the Terumo France activities, objectives and policies
   

Offer

Working for Terumo means contributing to society through healthcare. 

We offer an opportunity to work in a top performing team. An organisation where everyone is treated with respect. We strive to create a diverse, equal and inclusive work environment. We invest in our associates by offering a broad array of development opportunities. 

Linked with our core value Care, Terumo allows a hybrid way of working, combining office with home-based work. For the Regulatory Affairs team a regular presence in the office, combined with work at home is the guideline.

Terumo offers an attractive salary and benefits package including a savings plan provided by the company, RTT, hospitalization and long-term disability insurance, pension plan and meal vouchers when working from the office. 

Contact Person

Lukas Uytterhaegen - Talent Acquisition Business Partner EMEA