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Junior | Regulatory Affairs Specialist

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Regulatory Affairs
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190009CO Requisition #
Careers that Change Lives

As Junior Regulatory Affairs Specialist, you play an important role in patient safety and communication with different regulators. You are involved in processes that ensure regulatory compliance and safety of Medtronic medical devices once they are placed on the market.  
From our office in Heerlen we operate as the center of excellence for the whole EMEA region, connecting and building bridges between businesses, manufacturers and regulators.

A Day in the Life
You provide regulatory expertise to different stakeholders, like all Medtronic strategic business units (SBU), in country sales or regulatory persons, to ensure regulatory compliance related to:

  • Reporting of incidents to the Competent Authorities (CA) and Notified Bodies (NB);
  • Managing of Requests for Additional Information (RFAI) originating from CA and NB;
  • Coordination of Field Safety Corrective Actions (FSCA);
  • Advisory role for new and changing regulations.
Your main tasks and responsibilities include:

Responsibilities include the following and other duties may be assigned.

  • Reviewing Regulatory Decisions (RD) taken on complaints by the Strategic Business Units. Reviewing and timely submission of Regulatory Reports (RR) on content so they correctly reflect regulatory requirements;   
  • Interfacing with relevant stakeholders and monitor/facilitate RD and RR feedback process;
  • Review the Regulatory Decision of product events reported by CAs including review of non-reportable rationales to ensure compliance with Regulations;
  • Coordinate and assist for accurate and timely responses to RFAI from Competent Authorities and/or to Notified Bodies;
  • Manage the periodical reports to Notified Bodies or competent authorities;
  • Advisory role for new and changing regulations in EMEA countries;
  • Interfacing with relevant stakeholders and monitor/facilitate FSCA Coordination incl. set up of regional FSCA plan;
  • Supporting internal and external audits;
  • Supporting process improvement projects with lean six sigma/DMAIC methodology.
To be successful in this role you recognize yourself as a:

  • Bachelor’s Degree in Scientific or Regulatory/quality background;
  • Excellent communication skills both verbal as in writing;
  • Happy to work in a transactional tool-led environment;
  • Excellent command of the English language, both spoken and written;
  • Be able to learn quickly, analytical thinking.
To be successful in this role you recognize yourself as a:

  • Self-starter, accurate and a decision maker;
  • You have a strong passion for regulatory and continuous improvement;
  • You show a hands-on and result oriented approach to the application of quality 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;
  • Your excellent communication and presentation skills enable you to energize your audience and inspire change.
Your Answer
You want to develop yourself and together with us ensure regulatory compliance and safety of Medtronic medical devices?. This is your new challenge, do not wait any longer and click on the apply button. We are looking forward meeting you. 

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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The mission to improve access to healthcare globally is something we are all very proud to work hard toward achieving. Great people, fun atmosphere, big city salaries. The CEO is fantastic - he is a very clear communicator of the mission and is truly dedicating his life to achieving it.
Smart and committed coworkers. Mission driven. Good benefits. Good long term career opportunities. Company is large enough that you can always find interesting projects to work on.
Knowing that everyday your work helps to save lives makes it great place to work. Training on lean practices, quality and other. Excellent peers.

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