Regulatory Affairs & Quality Assurance Specialist

Regulatory Affairs & Quality Assurance Specialist

Straumann

Madrid, Spain

The RAQA Specialist reports directly to the RAQA Manager. The RAQA specialist is responsible for maintaining and ensuring that the company quality system meets all national market medical device regulations and the Straumann Group standards. The RAQA specialist is also responsible for ensuring that products and their labeling meet all regulatory requirements (national and international).

Main Tasks and Responsibilities

  • Manage and establish/maintain compliance with local (Spanish and Portuguese) health authorities (including company registration, new product submissions, establishing local communication/channels for compliance on medical device listings/classifications, management of CAPA system).
  • Manage and establish/maintain compliance with the EU market MDR (including CE Mark applications or self-declarations via technical files).
  • Manage and establish/maintain certification of ISO requirements (if applicable).
  • The RAQA specialist could also be the Importer Representative for company. The duty of this position is to be the point of contact for all regulatory communication for the company. (Reports, audits, registrations etc.).
  • Coordinator for the customer complaint system and generating the monthly customer complaint report.
  • Evaluating product failures and generating the evaluation report.
  • Conduct internal audits and coordinate and manage external audit schedules, correspondence and closing of findings.
  • Responsible for quality control and a coordinating quality system within the organization.
  • Responsible for the Documentation Control Process and Documentation Change Control Process.
  • Collaborating in for responding and reporting incidents to the Spanish and/or Portuguese health authorities.
  • Responsible the Quality Department.

Qualifications

  • A Bachelor of Science Degree with at least 3-5 years’ experience in Quality Assurance and Regulatory Affairs for Medical Devices or Pharma industry.
  • Good working knowledge of the following software programs: Microsoft Word, Excel, PowerPoint and Outlook. SAP user would be a plus.
  • Proofed experience performing internal/external audits.
  • Writing standard operating procedures and work instructions.
  • Developing Management Control Systems.
  • Experience managing documentation in English and fluent speaking the language is desirable.

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© EuroJobsites 2021

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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