Regulatory Specialist (Fixed Term - 1 Year)

Ecolab Temizleme Sistemleri

 Join Ecolab’s Regulatory team as Regulatory Specialist in Istanbul and help make the world cleaner, safer and healthier. We’re growing and need talented people like you to help us continue to protect the world’s most vital resources.

What’s in it For You:

• The opportunity to take on some of the world’s most meaningful challenges, helping customers achieve clean water, safe food, abundant energy and healthy environments
• The ability to make an impact and shape your career with a company that is passionate about growth
• The support of an organization that believes it is vital to include and engage diverse people, perspectives and ideas to achieve our best

What You Will Do:

• The purpose of this role is to provide registration expertise and support to enable business growth, compliance, customer value and competitive position. 
• Prepares, coordinates and secures necessary authorizations, registrations and/or documentation needed for regulatory compliance against Turkey regulations concerning products such as Medical Device, Biocide, Detergent and Cosmetic via Ministry portals.
• Implement registration programs to secure market authorizations primarily Turkey sales and provide regulatory support for export business of all divisions such as Food & Beverage, Institutional, Healthcare and Nalco Water done via distributors on nearby countries.
• Coordinate and execute the new biocidal registration submissions, license renewals for most of biocidal product types such as PT1, PT2, PT3, PT4, PT5, PT11 and PT12
• Work with the regulatory agencies in Turkey and Notified Body to ensure compliance of the company Ecolab with current and future regulatory requirements in scope of both MDD and MDR
• Support the business and serve as regulatory expert in cross functional projects, with good knowledge in Biocidal Regulation, Medical Device Regulation, Cosmetic Regulation and Detergent Regulation with applied standards.
• Support KKDIK team for the required registrations
• Monitor regulation changes to ensure continued compliance, 
• Research new information on regulatory requirements
• Partner with business leaders to enable growth with compliance to local regulations, 
• Respond to internal/external customer enquiries, 

Minimum Qualifications:

• Bachelor’s degree in chemistry, chemical engineering, pharmacology, toxicology or related life science degree, 
• Familiarity with especially Biocidal Regulation and 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)
• 3-5 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)
• Familiar with KKDIK (TR REACH) Regulation
• Ability to learn business and regulatory processes.
• Ability to read and interpret technical and regulatory documents.
• Good with Microsoft application, Excel, Word, Power point, etc.
• Fluent English with good written and verbal communication skills
• Project management experience is a plus.
• Result orientation, flexible, reliable and autonomous personality
• Team player; collaborative and able to work in cross functional teams
• Detail oriented, self-starter
• Excellent communication skills