Economic Operator Manager

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:
Quality

Job Sub Function:
Customer/Commercial Quality

Job Category:
People Leader

All Job Posting Locations:
Diegem, Flemish Brabant, Belgium

Job Description:

Overall purpose of job:

The Economic Operator Manager


* Ensures regulatory compliance and execution of EU Economic Operator Importer & Distributor requirements for Medical Devices, their components, packaging and others if applicable to facilitate EU market access for the full product life cycle including POLO products if applicable.


* Provides strategic guidance to the Commercial Quality (CQ) MedTech EMEA organization related to EU regulations and develops recommendations pertinent to the EU or wider business in accordance with EU regulations and relevant guidelines including POLO products if applicable


* Manages the introduction of process changes related to emerging regulations within the EU and leads communications with all stakeholders including POLO products if applicable


* Represents Belgian legal entity (GMED Healthcare BV) acting as Economic Operator for Importation & Distribution


* Supervises the EU Economic Operator verification team members and verification activities


* Supports EMEA countries outside of the EU on regulations where Economic Operator activities are required.

This role reports solid line to the Senior Manager Economic Operator EMEA to ensure regulatory, strategic and operational alignment, accountability and focus needed for effective execution of the EO verification check strategy in the EU.

This role also reports dotted line to the Regulatory Affairs EMEA organization.

Key responsibilities:

Management:


* Demonstrates deep expertise in the regulatory requirements for EU regulations and Belgian laws and other regulatory compliance related matters


* Partners closely with internal stakeholders across Johnson & Johnson to ensure that the compliance-related requirements are evaluated related to EU regulations and Belgian laws


* Provides clear and timely communication of new and changing requirements to the CQ MedTech EMEA team


* Educates internal stakeholders on EU regulatory requirements and integrating those requirements into procedures


* Ensures adherence to standard operating procedures and protocols and adjusts processes to improve efficiency or align with compliance requirements.


* Leads the day-to-day Economic Operator verification activities and ...