Regulatory Compliance Support Coordinator IV
Regulatory Compliance Support Coordinator IV
For our location in Heerlen, The Netherlands
Careers that Change Lives
At Medtronic, we strive without reserve for the greatest possible reliability and quality in our products and processes. The EMEA Customer Quality team within the Quality Operations and Transformation department focuses on compliance work: Complaint Handling, Field Actions, Product Hold Orders, Regulatory Reporting and Inquiries.
We are currently looking for a Regulatory Compliance Support Coordinator within the Field Action team.
A Day in the Life
The primary role is to perform administrative support for business processes. This includes support of the day-to-day activities within the QRA department, related to execution, handling and coordination of:
• Field Corrective Actions (FCA) for the EMEA region;
• Product Hold Orders (PHO) for the EMEA region;
• Reconciliation for Field Corrective Actions (FCA);
• Coordinate timely translation with central office of Field Action communication.
We offer you a position that allows you to work throughout different parts of the organization, and you will be in contact with different country and regulatory representatives.
Next to this, you will be involved in active improvement processes. You are expected to work independently on your assigned tasks and projects and will be part of the Regulatory Compliance Support team.
Your main tasks and responsibilities include:
Responsibilities may include the following, other duties may be assigned.
Provides process and system support to group and business processes for below activities:
• Interfacing with relevant stakeholders and monitor/coordinate for FCA reconciliation;
• Interfacing with relevant stakeholders and monitor/coordinate for PHO;
• Provide operational support on the vigilance process(es);
• Participate in and assist with audits (e.g. internal, Notified Body, Competent Authority);
• Improvement of processes and tools;
• Maintain department systems and documents/work instructions;
• Provide training on specific tools and processes.
Do you have what it takes?
• Minimum Bachelor’s degree;
• Minimum 6 years of relevant work experience;
• Understanding of impact of your work on RA Compliance. Preferred: demonstrated knowledge of regulatory Medical Device requirements related to Field Corrective Actions;
• Able to oversee systems and processes, solve problems / improve effectiveness of job area; experience with six sigma/DMAIC is a distinct asset;
• Organized/time management;
• Pro-active/continuous improvement mindset;
• Tool knowledge and affinity to work with systems (Excel, PowerPoint, SAP, FAMOUS, MMX, DocuSign);
• Service oriented;
• Happy to work in a transactional tool-led environment;
• Strong interpersonal skills and the ability to communicate well – verbally and in writing-
• Flexible to work in a hybrid environment.
To be successful in this role you recognize yourself as a:
• Self-starter and a decision maker;
• You have a strong passion for regulatory compliance and continuous improvement;
• You show a hands-on and result oriented approach to the application of tools;
• You are a distinct standout colleague, who’s able to establish relationships with colleagues in other countries and departments;
• Handling several tasks, priorities and projects at once poses no problem for you and you can work well in a high pace environment;
• You oversee the bigger picture, and are able to initiate and drive improvements;
• You have affinity (and preferably experience) with IT projects e.g. defining requirement as input for tool optimization, performing user acceptance testing;
• You have excellent communication and presentation skills.
We Offer
In our 5th Tenet of our Mission we recognize the personal worth of employees by providing an employment framework that allows personal satisfaction in work accomplished, security, advancement opportunity, and means to share in the company's success.
Also a competitive package is of course part of that. We offer a competitive salary and benefits package to all our employees:
• 28 holidays;
• Possibility to purchase 8 extra holidays days;
• Flexible working environment;
• Annual Incentive Plan % depending on company results;
• Pension scheme and group discount on healthcare insurances;
• Tax advantages on Commuting, Fitness plan, bicycle plan;
• Training possibilities via Cornerstone/Harvard Manage Monitor/GetAbstract;
• Employee Assistance Program and Recognize! (our global recognition program);
• Private Lease possibilities.
Your Answer
Is this the position you were waiting for? Then please apply directly via the apply button!
About Medtronic
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life.
We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.
Founded in 1949 as a medical repair company, we're now among the world's largest medical technology, services and solutions companies, employing more than 89,000 people worldwide, serving physicians, hospitals and patients in over 155 countries. With our European Operations Center for Distribution and Shared Services in Heerlen, the Bakken Research Center in Maastricht, our manufacturing facility in Kerkrade, and the Dutch sales office in Eindhoven, Medtronic Netherlands has more than 1,750 employees.
Whatever your specialty or ambitions, you can make a difference at Medtronic - both in the lives of others and your career. Join us in our commitment to take healthcare Further, Together.
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