ASSOC REGULATORY AFFAIRS SPEC

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Careers that Change Lives
The EMEA Center of Excellence for RF, as part of Pre-Market Regulatory organisation; this is a service organization in charge of providing Radio Frequency Certification/Type Approvals services to different Operating Units of the company.
The Associate Regulatory Affairs Specialist will report to the QARA Program Manager for RF in EMEA, and will be member of the Center of Excellence for RF (CoE RF).
Your good performance will allow you to grow in the organisation.

A Day in the Life
In this role you will be part of the EMEA CoE RF. You will be working in a broad network of Medtronic stakeholders from the different operating units, to understand their marketing plans and help to define RF certification plans to enable or support these marketing objectives.

You will help in Radio Frequency certification submission processes with different Telecom & Radiocommunication Authorities (Regulators) worldwide, with focus on the internal client’s priorities (Operating Units).

We offer you a position, in which you will represent the EMEA CoE RF team, that allows you to be active throughout different operating units and interaction with their engineering, R&D, regulatory, marketing and sales forces. Your focus area will be submitting RF certifications/type approval requests, follow up, maintain and recertification upon expiration. You will keep track of certification submissions and approvals mainly in EMEA, but also around the globe, in accordance with the marketing plan of the operating units, and you will help in the operations and administration of the CoE RF team.
Your duties include coordinating and responding inquiries from radiocommunications regulatory agencies, maintaining technical files and electronic document management systems, create scorecards and working with project teams to obtain RF approval for company medical devices/products.

Your main tasks and responsibilities include:
• Coordinate with the operating unit’s relevant stakeholders
• Establish RF certification plan
• Prepare RF submission deliverables.
• Coordinate in-country testing with local laboratories and third-party agencies.
• Submit Type Approval/Certification request with radiocommunication authorities (regulators)
• Follow up submissions until obtention of certification. Keep track of submissions, approvals and renewals.
• Create Interfaces with other Engineering, R&D, regulatory, marketing sales from operating units to serve, and to ensure collaboration and coordinated strategy to meet service goals and objectives.
• Accountable for obtaining the Type Approval/Certification with the radiocommunication authorities.
• Performs all other duties and tasks as assigned, including administrative tasks.

Do you have what it takes:
• Bachelor’s Degree in engineering (Telecommunications, Electronic, Mechanic, bioengineer or similar)
• 2+ years of relevant experience with a Bachelor’s Degree or 1+ years of relevant experience with an advanced degree.
• Strong oral and written communication skills
• Multi-Stakeholders management (focusing on interacting with operating units)
• Ability to work in matrix organization
• Ability to understand technical documentations, able to understand technical testing reports and RF/Safety reports, and with knowledge on medical devices and or radiocommunication devices and standards applicable to them.
• Independent and proactive but at the same time a Team Player; self -taught person and enthusiastic. Eager to learn.
• Problem solver and out of the box thinker.
• Attention to detail, analytical, computer literacy, communication, problem-solving, listening
• Experience in Regulatory is a plus.

To be successful in this role you recognize yourself as a:
• Experience with interpretation of RF regulations and standards (Safety, EMC, NFC, SRD, RFID, BTLE, WiFi, etc.)
• Experience with interpretation of technical information from Radio components.
• Experience with reporting schemes and multi-stakeholders’ coordination.
• Experience with the creating technical documentation based on R&D and engineering organisations.
• Experience with Microsoft Office: Mastery of Excel. Access, Publisher, etc., is a plus.
• Experience with Quality Management Systems: Agile is a plus.

Your Answer
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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 86,000 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 2,000 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.

Additional Information
  • Posting Date: Jan 13, 2021
  • Travel: No
Type vacature:
Intern

Vaardigheden

  • Er is geen minimale opleiding vereist
  • Voor deze functie is er geen minimale werkervaring vereist
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