QUALIFICATIONS AND JOB DESCRIPTION
Roles & Responsibilities
Acting as the primary point of contact for all type of regulatory affairs and quality related topics for Turkey and countries managed by Turkish organization (such as Azerbaijan, Uzbekistan, Tajikistan, Kirghizistan, Turkmenistan)
* Being in direct contact with the EMEA Headquarter RAQA organization to demand required documentation for the submissions and report the progress of the submissions in a continuous manner
* Taking necessary actions to register all the products that are sold by the company in UTS in a timely manner.
* Ensuring all the registrations and other required information in the UTS system are kept up to date in Turkey
* Managing Post market surveillance activities, including Field Safety Corrective actions. Making the reporting to the relevant parties in a timely manner and follow up.
* Monitoring the regulatory framework changes actively and creating the regulatory strategy accordingly.
* Interacting with local authorities in all aspects of regulatory activities
* Representing the company in local Medical Device Association in Regulatory Affairs Committee
* Ensuring the company is fulling all the local regulatory requirements and create action plan when necessary
* Acting as Quality management representative for ISO 9001: 2015
* Ensuring that quality management system and international standards are implemented and align with company policies/guidelines;
* Taking and suggesting all necessary actions for the continuity of ISO 9001:2015 certification and also improving the existing Quality management system.
* Supporting the compliance activities
Qualifications, Experience, Skills and Education Requirements
* 4 to 6 years of experience in Regulatory Affairs in Medical Devices/ IVD industry preferably. Pharmaceuticals can be an option.
* Familiarity with ISO 9001, ISO 13485 and medical device regulations are major assets and preferred.
* Ability to work in a multinational team environment.
* Strategic thinking, Problem solver and ability to multitask.
* Excellent communication skills
* Having no travel obstacle within Turkey or abroad
* Fluency in English is a must.