Diatron develops, manufactures and markets hematology analyzers, clinical chemistry analyzers, and
associated reagents for human medical and veterinary use.
At Diatron, we not only pride ourselves on the quality of our products, but also on the quality of our
support through our comprehensive product training programs and our excellent technical support and
customer service teams.

As a result of our international expansion we are looking for talented individuals who want to
be part of our global success.

Regulatory Affairs Specialist
Main roles:
As a Regulatory Affairs Specialist, you will be responsible for managing product registrations and
technical documentation for our IVD product portfolio. You will work with other departments on product
registration and regulatory compliance activities. You responsibilities will be:

Issue technical documentation as per 2017/746 EU IVDR and supporting documentation
Provide professional support to other departments to ensure compliance with the IVDR
Continuously analyze technical documentation for compliance, in case of identified GAPs, take
actions to ensure compliance
Analyze QMS procedures related to IVDR, make suggestions and update relevant QMS
procedures
Represent Regulatory on project teams providing regulatory feedback and guidance throughout
the product development cycle and coordinating team inputs for submissions
Coordinate the completion and submission of regulatory product files for timely and efficient
product registration
Lead in product registration applications in EU/Hungary and USA/FDA markets
Document, consolidate and maintain oral and written communications with distributors, OEM
partners, regulatory bodies, etc.
Establish and maintain procedures describing regulatory affairs activities according to the
Diatron Quality Management system

Knowledge, Skills and Experience:
Minimum College Degree or Equivalent on relevant field.
Minimum 2 years of experience in regulatory affairs within medical device (MD) or in-vitro
medical device (IVD) industry.
Strong English in spoken and written
Strong organizational, communication, interpersonal skills.
Precise, self assertive


What we offer:
Dynamic, team
Friendly, modern atmosphere
Carrier opportunities
Cafeteria

Language:
Fluency in written and spoken English
Fluency in written and spoken Hungarian


Working location:
Budapest

tu How to apply:

If you are interested in joining us, please send us a copy of your latest CV in both English and
Hungarian along with your salary requirements and earliest start date to the hr@diatron.com email
address.