Quality Compliance Assistance (m/f/d)

OVERVIEW

Reporting to the Director Post Market Quality, the Quality Compliance Assistant, will be responsible for supporting and executing Field Actions within the CEE Cluster for all BDX Business Units in line with the regulatory environment.

Main Responsibilities

Specifically relating to Quality Compliance Cluster, the Job Holder will:

• Engage and establish relationships with local BDX business functions to promote and represent the Post Market Quality function. Where applicable, the job holder will provide support to the local BDX business units in relation with the needs of their customers.

• Where applicable, provide periodic reports/data relating to activities for Quality management as necessary or as requested to track Cluster/regional specific goals.

• Execute any local compliance activities in line with local regulatory, legal and/or business requirements under the supervision of the Director Post Market Quality.

Specifically relating to Field Actions, the Job Holder will:

• Process Field Actions within the Central European Cluster. Dependent on the business impacted by the Field Action, this may include sending the customer notifications and receiving and logging the acknowledgment forms (reconciliation); follow up on customer acknowledgement and liaising with other functions (i.e. Customer Service, Technical Services, Sales and Marketing etc), to ensure timely closure of the Field Action and associated activities.

• Coordinating a cluster core business team associated with the Field Action (where applicable) and provide input and oversight to execute and close the Field Action in a timely manner.

• Support the EMEA Field Action Centre of Excellence in relation to obtaining information in order to answer any local Regulatory Agency queries; this may include liaising with other functions within the Central Europe Cluster to formulate a response.

• Supporting the EMEA Field Action Centre of Excellence by monitoring the overall reconciliation of the Field Actions in the Central Europe cluster and reporting the reconciliation to the EMEA Field Action Centre of Excellence.

• Maintain all records associated with the Field Action in Central Europe within the EMEA Field Action SharePoint site.

• Assist with the management and maintenance of any cluster-specific Field Action procedures/job aids.

• Undertaking any other duties as requested by the Director Post Market Quality to support the Vigilance CoE EEMA and the wider compliance organization.

Qualifications:

• Experience in the relevant subject area and in general office duties.

Required Skills:

• Demonstrated attention to detail and good written and verbal communication; fluency in German and English (oral and written).
• Demonstrated ability to adapt to changing needs of the organisation; including taking on broader aspects of a task and leveraging skills and knowledge to deliver better outcomes for the organisation.
• Capable of managing various activities at the same time and meeting internal and external deadlines.
• PC literate with a proficient knowledge of Microsoft (Word, Excel, PowerPoint, Outlook, SharePoint).
• High enthusiasm and motivation to work in a multicultural environment.