Economic Operator Manager

**Job Function**:
Quality

**Job Sub**Function**:
Customer/Commercial Quality

**Job Category**:
People Leader

**All Job Posting Locations**:
Diegem, Flemish Brabant, Belgium

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 team within EMEA related to all EU regulations pertaining to Medical Devices and components & other regulations as agreed e.g. Swiss Medo
- Supports and facilitates validation and tests of EOV system updates
- Manages, reports and improve Key Performance Indicators and metrics related to verification activities
- Communicates effectively with all stakeholders within Business Units such as Supply Chain, Customer Service, IT and others
- Supports announced and unannounced inspections by Competent Authorities and Notified Bodies as well as internal audits
- Liaison with local Competent Authorities
- Manages data in local and EU databases, e.g. FAGG and EUDAMED ( A Belgian citizenship is required to access the FAGG portal. )
- Identifies and facilitates continuous improvement activities
- Responsible for communicating business related issues or opportunities to next management level.
- Ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable.
- Responsible for ensuring personal and Company compliance with all local and Company regulations, policies, and procedures.
- Rapidly identifies and reports regulatory and quality concerns to Management and Franchise, investigates and suggests solutions to resolve them
- Reviews Quality related records and document changes in all applicable quality system IT Tools as applicable

Required Qualification and Core Competencies for the role:
Competencies:
Connect:

- Excellent Communication and presentation skills
- Skilled in establishing partnerships and collaboration with Business Unit partners, including Quality, Regulatory, Legal and other stakeholders.
- Ability to persuasively communicate and influence key stakeholders
- Embrace and lead a culture of inclusiveness and multi-cultural engagement through coaching and feedback to peers and the broader community in Medical Device in alignment with the J&J’s Leadership imperatives.
- Motivate and inspire our people, and work in a collaborative fashion to build consensus while operating in a matrix environment.
- Proactive and strategically orientated.
- Demonstrates deep domain expertise in the regulatory requirements for EU regulatory requirements for Medical Devices and components.
- Develop external relationships to ensure current and state of the art approaches.

Shape:

- Develop and foster an environment of innovative thinking and learning, through benchmarking methods, digital & automated solutions, training programs, process