Regulatory Affairs and Quality Specialist

Mene Research A. Ş.

University degree in Pharmaceuticals, Biomedical engineering, Chemical Engineering or Chemistry

Minimum 2 years of CE dossier preparation experience in a similar position at medical device industry,

Implementation of ISO 9001 & ISO13485 Quality Management systems

Preferably having knowledge GCP, GDP, GSP, GMP annex 13, Quality management system standard experience (ISO 9001.2015-)

Preferably experienced medical devices, health care, warehouse, clinical operation sector,

Fluency in reading, writing and speaking in English

Computer literate and proficient in MS Office and MS Outlook.

Knowledge of quality activities, change management system and leading meetings and projects

Good analytical thinking and problem solving skills

Ability to work in a fast-paced changing environment

Ability to perform multiple tasks simultaneously

JOB DESCRIPTION

Product registration/CE technical file preparation 

Writing, reviewing, and executing customer SOP protocols

Promoting quality achievement and performance improvement throughout the organization;

Providing compliance with national and international standards and legislation;

Setting up and maintaining controls and documentation procedures;

Identifying relevant quality-related training needs and delivering training;

Providing tests and procedures are properly understood, carried out and evaluated if necessary;

Liaising with customers' auditors and implementing the execution of corrective action and compliance with customers' specifications;