Regulatory Specialist

PERGO MEDİKAL VE İLAÇ SANAYİ ANONİM ŞİRKETİ

QUALIFICATIONS AND JOB DESCRIPTION

Would you like to be part of a winning team?

Pergo is an innovative and high end medical devices research, design and manufacturing company. Pergo has been established with 35+ years of industry experience and we have been overperforming market grow significantly and consistently. As of 2020, Pergo products are actively consumed by end users in 73 countries, 6 continents. 

Summary of our spirit is "Passion for Better". We encourage our employees to carry out their creative ideas in a team oriented, technological and demanding work environment. We prioritize doing business with integrity and respect for our employees and all the parties we interact with. If you are looking for a company, which is governed according to sound principals and managed professionally based on the science and technology, your future with us will be in safe hands.

Currently we are looking for experienced Quality Assurance Engineers.

Requirements:

·         Minimum 4 years of experience in relevant position; 

·         Minimum 4 years University degree in engineering (preferably in bioengineering or medical engineering);

·         Knowledge of testing and measurement systems;

·         Proficiency in using statistical methods;

·         Excellent organization, communication, data analysis skills;

·         Proficiency with Microsoft Office products; knowledge of database applications;

·         Fluency in English;

·         Exceptional Communication, presentation skills with the ability to convey complex issues clearly and the ability to persuade;

·         Strong attention to detail.

Job Description:

·         Establish, implement and maintain procedures and processes needed for the quality management system according to relevant international and national standards;

·         Prepare monthly reports needed for the management review;

·         Ensure the promotion of awareness of regulatory and customer requirements throughout the organization;

·         Coordinate the internal quality management system and product audits;

·         Coordinate the relations with all third party regulatory organizations;

·         Coordinate all risk management activities related to the quality management system and medical devices;

·         Regulatory registration and certification of the products in countries where operations are is targeted.  (USA, Canada, South America, Europe, Australia);