regulatory affairs specialist - remote work, warszawa

posted
location
warszawa, mazowieckie
job type
permanent
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job details

posted
warszawa, mazowieckie
vacancies
1
experience level
powyżej 24 miesięcy

job type
permanent
job category
Industry
contract type
umowa o pracę
working time
pełen etat
work system
podstawowy

contact

alicja kozłowska+48 605303807
reference number
/59/03/2021/AK - 68900

job description

Are you open to working at in an international company? Do you have experience in Quality and Regulatory Affairs? If yes, we are looking for you!

what we offer

  • Stable employment,
  • remote work,
  • attractive salary and annual bonus,
  • access to internal and external training,
  • opportunity to growing in a dynamic company,
  • attractive work in an international environment,
  • individual medical care, Multisport card, and Group life insurance.

your tasks

  • Working with international registrations, process improvements, regulatory maintenance, and lifecycle,
  • supporting production projects and the ongoing contemplation of EU IVDR/MDR regulation,
  • international registration by compiling dossiers to obtain approvals worldwide,
  • legislation monitoring and being able to translate this and implement it in the company,
  • maintain market approvals and current documents within responsibility area,
  • support in process improvements and creation of SOP,
  • compile, submit and support International Registrations,
  • sign statements related to international registrations.

what we expect

  • High education: preferable in Science, engineering, pharmacy, biology or the like,
  • minimum of 2 years experience,
  • experience with project management and cross-functional projects,
  • knowledge in Quality management systems,
  • knowledge of regulations related to the FDA (21 CFR Part 820), ISO 13485
  • language skills- fluent English and Polish .

Agencja zatrudnienia – nr wpisu 47