Regulatory Affairs Specialist ( Temporary ) İş İlanı
İşveren Hakkında
QUALIFICATIONS AND JOB DESCRIPTION
We are looking for a " Regulatory Affairs Specialist " for our multinational client which is operating in the Heathcare sector.
Qualifications:
- Bachelor’s degree in scientific, technology or legal disciplines
- Strong analytical skills
- Ability to work in a team environment with minimal supervision on projects and activities
- Fluent English (reading,speaking,writing)
- Experience in a medical device or pharmaceutical industry.
- Experience working across cultures/countries/sites.
- Progressive regulatory affairs experience in medical device or pharmaceutical industry or medical Product regulation agencies, including knowledge and experience applying drug or device laws and regulations
- Residing or able to reside in Ankara or Istanbul
Job Description:
- Analyze and communicate changes and proposed changes to country regulations through Regulatory Intelligence and implement strategies,
- Support regulatory compliance and optimization of quality system procedures relating to new product registration submissions and postmarket reporting through the development, maintenance and improvement of documented processes,
- Create regulatory compliance / project plan with Product RA to ensure all requirements are met for country submissions and liaise with relevant personnel to ensure appropriate, timely input is provided for submissions,
- Partner with Product RA to review advertising and promotion materials for country or regional compliance and approve these as required,
- Work with Product RA and Pre Market CoE for countries with license expiration requirements; establish plan and deliverables for timely submission for renewal of license Postmarket.
Manpower, Türkiye İş Kurumu’ndan 18.8.2016 tarihli ve 6 no’lu Özel İstihdam Bürosu izin belgesi ve 3.6.2017 tarihli Geçici İş İlişkisi Yetki Belgesi sahibidir. İş arayanlardan hiçbir ad altında menfaat temin edilmez ve ücret alınmaz.
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