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REGULATORY AFFAIRS SPECIALIST - MEDICAL DEVICE ?stanbul Michael Page ?stanbul

REGULATORY AFFAIRS SPECIALIST - MEDICAL DEVICE ?stanbul

?stanbul
2020-11-18 04:30:18
REGULATORY AFFAIRS SPECIALIST - MEDICAL DEVICE ?stanbul
• Leading global company
• Great career opportunity

Mü?terimiz Hakk?nda

Our client is one of the leading companies providing hygiene and infection prevention solutions.

?? Tan?m?

I
• mplementing registration programs to secure market authorizations primarily Turkey sales and providing regulatory support for export business of Healthcare Division done via distributors on nearby countries;
• Preparing, coordinating and securing necessary authorizations, registrations and documentation needed for regulatory compliance against Turkey regulations concerning Healthcare Division products (Medical Device, Biocide, Detergent and Cosmetic Regulations);
• Providing regulatory guidance during the entire life cycle of non-active Medical Devices for the product portfolio of Healthcare Division;
• Working with the regulatory agencies in Turkey to ensure compliance of the company with current and future regulatory requirements;
• Supporting the business and serve as regulatory expert in cross... functional projects, with good knowledge in Medical Device Regulations and applied standards;
• Monitoring regulation changes to ensure continued compliance;
• Researching new information on regulatory requirements;
• Partnering with business leaders to enable growth with compliance to local regulations.

A
rad???m?z Profil

H

aving a Bachelor's degree in chemistry, chemical engineering, pharmacology, toxicology or related life science degree; Familiarity with Medical Device Regulations and harmonized standards (upcoming 2017/745 EU Medical Device Regulation, MDD 93/42 and harmonized standards such as EN ISO 13485, EN ISO 14971 or MEDDEV guidelines); 2-5 years professional experience in the area of Regulatory Affairs; Experience in the area of non-active Medical Devices; biocide, cosmetic and detergent knowledge is an advantage; Experience with governmental regulatory programs such as MOH and other local or international regulations; Familiar with Hazard communication side (MSDS, labels, GHS); Ability to read and interpret technical and regulatory documents; Fluent English and Good with Microsoft application; Team player; collaborative and able to work in cross functional teams with excellent communication skills.

Teklif Edilenler

G

reat career opportunity in a leading global company.

?leti?im:
Cagla Sengoz

?lan Referans Kodu: 20334
?stanbul Turkey
REGULATORY AFFAIRS SPECIALIST - MEDICAL DEVICE ?stanbul Michael Page ?stanbul
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