Regulatory Affairs International Specialist (f/m/d)

Firma Hamilton Medical AG
Bereich Quality Management und Regulatory Affairs
Standort Home Office Rumänien (RO), Timisoara, jud. Timis (RO)
Home-Office Pensum Up to 100 %
Anstellungsart Mitarbeiter/in unbefristet
Referenznummer JR-3914

True to the vision “We drive innovation to improve people’s lives”, the Hamilton companies have been providing solutions for the health sector since 1950. We are an innovative pioneer in the fields of ventilators, automated pipetting, sample management and in the development of process sensors.

Hamilton Medical is a leading manufacturer of intelligent ventilators. Whether in ICUs, during emergency rescue transport or an MRI scan – our solutions cover a multitude of patient groups, applications and environments.

Job Description:

  • You are responsible for the registration and approval of our medical devices worldwide
  • You create dossiers and documents for registrations and approvals
  • You coordinate the timely provision of all necessary documents and information with the departments involved
  • You organise translations, certifications, apostilles and the mail order of documents
  • You process enquiries from authorities and partner companies
  • If required, you will support audits by international authorities
  • Regulatory review and approval of trade products
  • Manage regulatory documents in the internal document repository

Professional experience & skills desired to have:

  • You have knowledge in the field of regulatory affairs
  • Ideally, you have experience with international registrations and approvals in the field of medical devices
  • You are fluent in English and can write documents confidently in English
  • German language is a plus
  • Good communication and problem solving skills
  • Excel knowledge
  • Self-responsible, personal motivation, analytical

How to apply:

Send us your resume at jobs.hce.ro@hamilton-ce.com or via the "Apply" button below.

Obtain more information via telephone +40356 635 056

Only suitable candidates will be contacted for interview. Please note that your resume will be entered in our database and may be used in further recruitment projects.

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