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.

• 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

• 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.

• Develop and foster an environment of innovative thinking and learning, through benchmarking methods, digital & automated solutions, training programs, process excellence tools and methodologies.
• Promote, seek, and lead innovative initiatives to improve verification checks performance.
• Ensure the integration of appropriate risk management with current and emerging trends.

• Maintain open conversations with key stakeholders to sustain and continuously improve the processes based on diverse perspectives.
• Take ownership and accountability for the operational and regulatory outcomes of verification process.
• Strong results-orientation and sense of urgency
• Solid capacity to analyze, interpret and synthesize regulation and guidelines
• Strong capability of self-awareness and adaptability

• A minimum of a bachelor’s degree or equivalent required.

• Advanced degrees and education in pharmacy, medicine, engineering, or science.
• A minimum of 5-8 years of medical device and/or medicines regulatory and/or quality experience required in an International Company.
• Process Excellence (Lean, six sigma) experience across diversified business areas or equivalent quality standards programs.
• Exceptional written and verbal communications skills
• Knowledge of quality and risk management
• Knowledge of emerging medical device & other regulations impacting product market placement.
• Experience as an influential leader and/or project leadership experience
• Demonstrated track record of process improvements, turn around and transformations.
• Demonstrated strategic thinking capabilities
• Sound business skills, including financial acumen and business planning
• Excellent decision-making and problem-solving skills
• Strong planning, project management, and change management expertise
• Working knowledge of the business E2E processes overall (from Business Unit, Supply Chain, EO, Commercial)
• Ability to build and nurture positive relationships with business partners in a matrixed environment (e.g., Supply Chain, Regulatory Affairs, Deliver, Quality groups, IT, various Business Units)
• Team building and development capabilities
• Team collaboration skills and coaching skills
• Language: English (fluent), French and Dutch (conversational)

eQuest