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Regulatory Affairs_Clinical Trials

Hays Czech Republic, s.r.o.

Place of work
Praha, Česko
Contract type
Wage (gross)
From 55 000 Kč/month

Information about the position

Job description, responsibilities and duties

Pharmaceutical company focusing on medical device portfolio are currently seeking for full-time, Prague office-based experienced Regulatory Affairs Specialist for clinical trials.

RAS will be responsible for preparation documentation packages for clinical trials in the EMEACLA region for in-country RA submission to local Competent Authorities. Assess changes to the clinical trials and provide guidance to the stakeholders. In EU conduct the submissions of clinical trials in the Eudamed database (once available). Support RA Manager in monitoring proposed and current regional regulations and guidance, assessing impact of such regulations and guidance on Edwards processes and systems and in proposing suggestions on handling.

Suitable profile for this role has degree level or equivalent in natural science, previous experience in clinical trial submissions preferable (other related activity also an option), preferably up to 3 years’ experience in regulatory environment with responsibility for clinical trials with medical devices. English language is the must, any other language is a plus. Solid knowledge and understanding of at least regional regulations relevant to clinical trials and medical devices in general, for all classes.

The company is able to offer partnership with the the global leader in patient-focused medical innovations, multicultural environment, motivated salary and benefits package

Company on whose behalf the position is being filled

Chemical industry, manufacture of pharmaceutical products

Pharmaceutical company focusing on medical device portfolio

Requirements for the employee

Candidates with education suit the position

University education (Bachelor's degree)

Language skills

English - Advanced (C1)

Driving licence



Brief description of the company

Hays is a global leader in specialist recruitment, placing professional candidates in permanent and interim jobs.

The company is a holder of a licence to offer recruitment services.

Company address

Hays Czech Republic, s.r.o.
Olivova 4/2096
110 00 Praha 1


Kontaktní osoba: Adéla Slabová
E-mail: poslat životopis
ID: 4153679  Datum zveřejnění: 2.9.2021  Spodní hranice mzdy (brutto): 55 000 Kč/month