Job Description Summary

Reporting to the Manager Post Market Quality, the Post Market Quality Specialist, will be responsible for executing key post-market activities such as complaints (where applicable), vigilance reporting and Field Actions within the Central Europe Cluster for all BDX Business Units in line with the regulatory environment.

Job Description

As Post Market Quality Specialist you will be:

• Processing European serious incident reports for the MDS business or other businesses through the dedicated electronic system and maintain the associated documentation, as required

• Supporting and responding to Competent Authority enquires relating to specific MDS or other business units cases as required

• Supporting the ongoing review and evolution of the CoE to ensure the process is comprehensive, efficient and reflective of best practice within BD and within the Medical Device industry. The job holder will also support implementing the requirements of the MDR and the IVDR and any other EMEA regulatory requirements in relation to Vigilance

• Sending the customer notifications and receiving and logging the acknowledgment forms (reconciliation); follow up on customer acknowledgement and liaising with other functions, to ensure timely closure of the Field Action and associated activities

• Coordinating a cluster core business team and provide Post Market Quality 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 acquiring information in order to answer any local Regulatory Agency queries; this may include liaising with other functions within the Eastern European countries of 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 Eastern European countries of the Central Europe cluster and reporting the reconciliation to the EMEA Field Action Centre of Excellence

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

We expect from you:

• Degree level or equivalent qualification in a relevant subject area

• A minimum of 2 years’ experience in medical device QA and/or RA or experience as a nurse

• Proven knowledge of the European regulatory and legal requirements in the field of Medical Devices and any specific local Cluster requirements

• Proven attention to detail and good written and verbal communication; fluency in local language and English

• Proven ability to adapt to changing needs of the organisation; including seeking broader aspects of a task and leveraging skills and knowledge to deliver better outcomes for the organisation

• Capable of leading various activities at the same time and meeting internal and external deadlines

• High passion and motivation to work in a multicultural environment.

• Potential for occasional European/International travel

Why join us?

A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do every day. You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.

Becton, Dickinson and Company is an Equal Opportunity Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, or any other protected status.

Primary Work Location

DEU Heidelberg - Tullastrasse

Additional Locations

Work Shift