REGULATORY AFFAIRS SPECIALIST - MEDICAL DEVICE ?stanbul Leading global company Great career opportunity
Our client is one of the leading companies providing hygiene and infection prevention solutions.
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
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.
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