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Regulatory Affairs Internship

Apply now Job no: 614141
Work type: Intern (Student)
Location: Amsterdam
Categories: Quality & Regulatory, Students & Graduates, Western Europe, Individual Contributor

Change people’s lives and love what you do! Cochlear develops world-leading medical devices that help people hear. As a top 100 medical device company and market-leader in implantable hearing devices, more people choose a Cochlear-branded cochlear implant system than any other. Our employees tell us that the number one reason they enjoy working for Cochlear is the opportunity to make a difference to people’s lives.

We have an excellent opportunity for an intern in regulatory affairs to join our EMEA regulatory affairs department as Intern, Regulatory Affairs – based either in The Netherlands, Germany, Italy, Austria or Belgium and reporting directly to the Director Regulatory Affairs, EMEA. This role could be working remotely. This role is a full-time opportunity for at least 6 months internship that can be renewed to another 6 months as needed.

The EMEA (Europe, Middle East, Africa, Russia, Central Asia, Central Eastern Europe) Regulatory affairs team leads Cochlear’s efforts owing the CE mark submission and approvals with our notified bodies as part of the Global Regulatory Affairs activities, in addition to lead and maintain the regulatory approvals and licenses in the related countries in EMEA that allow us to deliver the outstanding products we develop and manufacture to our customers.

 

This is chance to get insights into Regulatory Affairs and with the regulatory team in EMEA and at Global at Cochlear.

Key responsibilities:


Responsibilities may include the following and other duties may be assigned.

  • Develop the Regulatory monthly planning and compile the regulatory report in coordination with the regulatory team in EMEA.
  • Develop the regulatory requirements databases in coordination with EMEA regulatory team.
  • Analyse the available regulatory tools and provide suggestions on how to continuously improve to ensure one source of data.
  • Support in some regulatory projects or workshops as led by Regulatory Affairs team or Director.
  • Support in developing the regulatory processes and related procedures or Work instructions as required and mainly for EU as part of the global Quality management system.
  • Could support in compilation of regulatory technical documentation/ dossiers for some specific regions or projects as applicable.
  • Could support in regulatory transitions plans and projects as required.
  • Organize regulatory meetings with notified body or regulators and prepare agenda, minutes and follow-up in coordination with regulatory team in EU.
  •  Could support other regulatory activities as required.

Qualifications

  • Undergoing a university degree e.g. engineering or life science. Preference for the candidates who are undergoing regulatory affairs studies.
  • Industry experience of Medical devices in an industry is not necessary, but an interest in getting an insight in the Medical devices industry. Preference for the candidates who had some internship in regulatory or clinical or quality in  Medical devices industry.
  • Capability to establish and use internal networks to acquire related experience.
  • Strong English language skills, fluent in another language eg Dutch is nice to have.
  • Microsoft office tools knowledge.
  • Strong project management
  • Process or quality oriented is highly desirable.
  • Organized, details focused, fast in learning, capable to work in a matrix organization.

Cochlear can offer:

  • The Work - A high impact job supporting world leading technology
  • The Organisation – The global leader in implantable medical device hearing technology
  • The Opportunity – To make a difference to the quality of people’s lives

This is your chance to be part of a premier organization with a great culture, working in a dynamic, growing and rapidly evolving environment to deliver outstanding results that benefit our customers every day. Be part of something purposeful and APPLY now by clicking on the link below and see your career grow!

 

Equal opportunities 

Cochlear is committed to providing equal opportunities to avoid unlawful discrimination on the grounds of race, sex, disability, sexual orientation, religion/belief or age. 

In line with our corporate ethics and statutory obligations we strive to ensure that the work environment is free of harassment and bullying and that everyone is treated with dignity and respect - this is an important aspect of ensuring equal opportunities in employment.



Advertised: W. Europe Standard Time
Anticipated Application Closing: W. Europe Standard Time

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