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Regulatory Affairs_Clinical Trials
Hays Czech Republic, s.r.o.
Place of work
Praha, Česko
Praha, Česko
Contract type
full-time
full-time
Wage (gross)
From 55 000 Kč/month
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
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
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
B
Advertiser
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.
The company is a holder of a licence to offer recruitment services.
ID: 4153679
Posting date: 2.9.2021
2021-09-02
location: Prague Position: Regulatory Affairs Specialist Company: Hays Czech Republic, s.r.o.
Lower salary limit (gross): 55 000 Kč/month