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Regulatory Compliance Support Coordinator

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Office Support
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19000AFJ Requisition #

Careers that Change Lives

At Medtronic, we strive without reserve for the greatest possible reliability and quality in our products and processes. The Regulatory Competence Center of the RC&TS (Regulatory Compliance & Technical Service) department focuses on compliance work: Complaint Handling, Vigilance, Product Hold Orders, Regulatory Inquiries and Regulatory Release.

 

We are currently looking for a Regulatory Compliance Support Coordinator.

A Day in the Life

 

The primary role is to support business processes. This includes support of the day-to-day activities within the RC&TS department, related to execution, handling and coordination of:

 
  • Product Hold Orders (PHO) for the EMEA region
  • Reconciliation for Field Corrective Actions (FCA)
  • Submission of vigilance reports to authorities
 

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 both as a SME or as a lead. 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 tool;
  • Provide training on specific tools and processes.

Do you have what it takes:

  • Min. Bachelor Degree, with min 5 years of work experience;
  • Tool knowledge and affinity to work with systems (SAP, Famous, Documentum, GCH, MMX, excel);
  • Operational & transactional execution;
  • 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 asset;
  • Service oriented;
  • Happy to work in a transactional tool-led environment;
  • Excellent command of the English both spoken and written.
 
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 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.

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.


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