QARA Assistant

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 a Quality and Regulatory Assistant (QARA) for our French entity, your role involves collaborating closely with the Terumo Europe Quality and Regulatory teams. Your mission is to acquire and organize essential documentation and information related to French ANSM declarations. Additionally, you’ll address the requirements of the tender department and cater to our valued internal and external customers’ needs.

In this multifaceted position, you’ll also provide crucial support to the QARA Lead. This includes managing complaints related to finished products and overseeing safety corrective actions. Furthermore, you’ll engage with local authorities, ensuring compliance within the quality framework.

As part of your responsibilities, you’ll keep a vigilant eye on local regulatory developments and conduct impact analyses. Your contributions will play a vital role in maintaining high standards and ensuring the well-being of our stakeholders.

As a Quality and Regulatory Affairs Assistant, your mission is to ensure the highest standards of quality and compliance within our organization and specifically for Terumo France. In close collaboration with the Terumo Europe Quality and Regulatory teams, you'll make a direct impact on patient safety and customer satisfaction.

For this position we are exclusively looking to hire in France. We offer a hybrid working model with weekly presence in our Paris based office. 

Job Responsibilities

Complaint Management and Safety Oversight

• For Terumo France you will timely and accurately follow-up product complaints according to Terumo EMEA procedures and instructions
• Accordingly you will record and follow up on customer complaints and materiovigilance reports and handle all related correspondence with customers and authorities
• In case of unfavourable trends or serious patient injury you will escalate to the local QARA Lead and the responsible EMEA product owner
• You will be involved in the training of local personnel on effective complaints handling and related procedures

Regulatory Support

• You will assist the QARA Lead in contacting the Ministry of Health or ANSM for post-market monitoring activities and healthcare advertising
• You will support the local sales organisation in providing all necessary product declarations and related documentation for tenders
• You will collaborate with EMEA product specialists to create and update technical cards tailored to local needs
• You offer support in reviewing local promotional materials for regulatory compliance

Local Regulatory Watch and Impact Analysis

• You will monitor local regulatory changes and conduct impact analyses and communicate to and follow-up with all relevant internal stakeholders

Customer Interaction

• You will respond to various customer requests, including specific statements and product-related questionnaires ensuring an excellent customer experience

Profile Description

Education: Bachelor’s degree in a scientific field.
Experience: Minimum of 1 year in a similar role 

Skills and Attributes:
Precise and Accurate: Attention to detail is crucial
Proactive: Take initiative and anticipate needs
Confident Communicator: Comfortable reaching out to associates across the entire Terumo organization
Supportive: Foster a positive and collaborative work environment
Growth Mindset: Willingness to learn and adapt
Efficient: Optimize processes and workflows
Prioritization Skills: Manage tasks effectively
Organizational Complexity: Ability to navigate complex structures and processes

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

Please provide your resume and cover letter in English.

Lukas Uytterhaegen - Talent Acquisition Business Partner EMEA