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Ovaj oglas je istekao 21.06.2016. i više nije aktivan.
Sadržaj oglasa prikazan je isključivo u informativne svrhe.
Trenutno aktivne oglase pogledajte na www.posao.hr.
Ovaj oglas je istekao 21.06.2016. i više nije aktivan.
Sadržaj oglasa prikazan je isključivo u informativne svrhe.
Trenutno aktivne oglase pogledajte na www.posao.hr.
Regulatory Affairs Associate (m/f)
Oglas je istekao
Poslodavac:
Kategorija:
Mjesto rada:
South East Europe Region
Rok prijave:
21.06.2016.
O poslu
Opis radnog mjesta:
Regulatory Affairs Associate (m/f)
Health Care Business South East Europe Region
Job Summary:
To assume responsibilities for conducting assigned, well-defined regulatory tasks to ensure compliance with medical device and pharmaceutical legal requirements in SEE Region as well as corporate policies. Conduct product/ company registrations with authorities and provide / assist in pharmacovigilance activities. Support Health Care business in coordinating tender process.
Job Duties:
• Submission of health care product / company registrations to relevant authorities via local MOH processes
• Maintaining overview of registrations and preparing registration plan
• Monitoring the medical device and pharmaceutical legislation relating to registrations and pharmacovigilance and communicating in the organization
• Assisting in product recall activities
• Assisting in product complaint reporting
• Assisting in pharmacovigilance reporting
• Participation in Ministry of Health company audits
• Liase with external consultants ( where appropriate) on legislation impacting medical devices and pharmaceuticals
• Liase with design centers on product changes requiring registration amendments or new registrations
• Acting as a local “qualified person” for pharmacovigilance and or good distribution practice for drugs
• Business support including: Management of bid and tender process; Processing authorization, certification and documents related to product training, required by local law
Health Care Business South East Europe Region
Job Summary:
To assume responsibilities for conducting assigned, well-defined regulatory tasks to ensure compliance with medical device and pharmaceutical legal requirements in SEE Region as well as corporate policies. Conduct product/ company registrations with authorities and provide / assist in pharmacovigilance activities. Support Health Care business in coordinating tender process.
Job Duties:
• Submission of health care product / company registrations to relevant authorities via local MOH processes
• Maintaining overview of registrations and preparing registration plan
• Monitoring the medical device and pharmaceutical legislation relating to registrations and pharmacovigilance and communicating in the organization
• Assisting in product recall activities
• Assisting in product complaint reporting
• Assisting in pharmacovigilance reporting
• Participation in Ministry of Health company audits
• Liase with external consultants ( where appropriate) on legislation impacting medical devices and pharmaceuticals
• Liase with design centers on product changes requiring registration amendments or new registrations
• Acting as a local “qualified person” for pharmacovigilance and or good distribution practice for drugs
• Business support including: Management of bid and tender process; Processing authorization, certification and documents related to product training, required by local law
Vrsta posla:
stalni radni odnos
Županija:
Sve županije
Država:
South East Europe Region
O zaposleniku
Znanja i kvalifikacije:
Qualifications:
• Accredited university degree in pharmacy or natural science
• Good communication and team skills
• Ability to work independently
• Computer literacy and a working knowledge of applicable software (MS Office, Excel)
• Ideally previous experience in health care regulatory affairs or quality management systems
• Good English language skills (verbal and written)
If you feel attracted by the above-mentioned position – please send your application in English within 14 days to [email protected]
• Accredited university degree in pharmacy or natural science
• Good communication and team skills
• Ability to work independently
• Computer literacy and a working knowledge of applicable software (MS Office, Excel)
• Ideally previous experience in health care regulatory affairs or quality management systems
• Good English language skills (verbal and written)
If you feel attracted by the above-mentioned position – please send your application in English within 14 days to [email protected]
Minimalna stručna sprema:
Fakultet
Strani jezik:
engleski
Poznavanje rada na računalu:
dobro
