Regulatory Compliance Support Coordinator II
Regulatory Compliance Support Coordinator
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);
- Improvement of processes and tools;
- Provide training on specific tools and processes.
Do you have what it takes:
- Minimum Bachelor’s degree;
- Minimum 2 years of relevant work experience;
- Tool knowledge and affinity to work with systems (Excel, PowerPoint, SAP, FAMOUS, MMX, DocuSign);
- Understanding of impact of your work on RA Compliance;
- Organized/time management;
- Pro-active/continuous improvement mindset; experience with six sigma/DMAIC is a distinct as-set;
- Service oriented;
- Happy to work in a transactional tool-led environment;
- Excellent command of the English both spoken and written;
- 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 in-put for tool optimization, performing user acceptance testing;
- You have excellent communication and presentation skills.
Your Answer
Is this the position you are waiting for? Don't hesitate and send us your CV and cover letter by using the apply button.
About Medtronic
As a global leader in medical technology, services and solutions, Medtronic improves the health and lives of millions of people each year. We believe our deep clinical, therapeutic and economic expertise can help address the complex challenges - such as rising costs, aging populations and the burden of chronic disease - faced by families and healthcare systems today. But no one can do it alone. That’s why we’re committed to partnering in new ways and developing powerful solutions that deliver better patient outcomes.
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 85,000 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 Medtronic Eindhoven Design Center and Dutch sales office in Eindhoven, Medtronic Netherlands has more than 1,500 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.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
