quality assurance and regulatory affairs manager - μαρκόπουλο

posted
contact
Dora Tzevelekou, Randstad Hellas
job type
permanent
apply now

job details

posted
location
μαρκόπουλο, attica
sector
life sciences
job type
permanent
reference number
30600
contact
Dora Tzevelekou, Randstad Hellas
phone
2166001387

job description

Do you see yourself being the one to continually improve the quality and compliance of an organization with exports to over 70 countries worldwide?

Are you a dynamic ,self-driven and experienced Quality assurance and Regulatory affairs Manager?

Then this role of Quality assurance and Regulatory affairs Manager is definitely for you!

If you want to be part of one of the fastest growing medical devices manufacturing company, then apply now forthe role of Quality assurance and Regulatory affairs Manager. 

benefits

The company offers the following benefits for this Quality assurance and Regulatory Manager position:

  • Competitive remuneration package depending on qualifications and experience
  • Dynamic and modern working environment
  • Opportunities for professional development
  • Continuous education and training

responsibilities

The role of the Quality assurance and Regulatory affairs Manager, is the successful maintenance of the quality certificates ISO 9001, ISO 13485 and MDSAP that the company has obtained, as well as EU CE marking process and registration process for medical devices within the EU and other countries.

The Quality Assurance and Regulatory Affairs manager collaborates with members of other departments to achieve compliance and goals laid down.

Main Responsibilities 

  • Maintain an ISO 13485 Quality Management System
  • Develop, implement and improve Company’s SOP’s
  • Monitor product compliance and review processes in order to ensure that both are aligned with current regulatory and/or statutory requirements
  • Compile technical documentation for Class I and/or Class IIa medical devices
  • Interpret the regulatory requirements for medical devices in the EU and/or other jurisdictions
  • Support compliance to European, FDA and other applicable countries requirements
  • Communicate with regulatory agencies on administrative matters
  • Keep track of international legislation, guidelines for countries where the company exports
  • Perform internal audits
  • Coordinate 2nd and 3rd party audits (Notified bodies, Competent Authorities, FDA, OBL)
  • Review company practices under a risk-based approach and provide advice on changes to the Quality Management System

qualifications

The ideal candidate for the position will be expected to have the following:

  • At least four (4) years of professional experience in quality management systems (or in regulatory affairs) within a manufacturing medical devices or pharmaceutical company.
  • A diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognized in law, medicine, pharmacy, engineering or another relevant scientific discipline
  • Strong Knowledge of ISO 13485, ISO 9001 and ISO 14971
  • Knowledge of FDA requirements and in general MDSAP requirements will be considered as an asset
  • Experience in internal audits
  • GCP knowledge will be considered an asset
  • Experience in audits from notified bodies, competent authorities from Greece and abroad (e.g. FDA, Health Canada, Russia etc.)
  • Excellent command of spoken and written English
  • Awareness of legislation
  • Ability to meet deadlines

skills

  • Team-work
  • Attention to detail
  • Analytical thinking
  • Strong organizational skills
  • Strong project management skills
  • Flexibility, dependability and diligence

experience

 At least 4 years in quality management systems and/or regulatory affairs.

educational requirements

  • Bachelor

information

If this sounds like you, we want to hear from you today! Should you need additional information, please contact me Dora Tzevelekou at 2166001387.

Please note that after the screening of all the CVs received, we will only contact the candidates who meet the requirements of the job to arrange an interview. All applications are considered strictly confidential.

Please note that for transparency and equity reasons, only those applications made online via our site will be assessed. After the screening of all the CVs received, we will only contact the candidates who meet the requirements of the job to arrange an interview. ​ All applications are considered strictly confidential.