QA/RA Compliance Specialist - Heerenveen

Function Group: Quality/RA / QA Officer

Organization

For an organisation that develops, produces and sells innovative equipment and application software for hospitals for the nuclear medicine and (radio) pharmaceutical industry, we are looking for a QA/RA Compliance Specialist to strengthen the team.

Function

Within this role you will work in a small quality team in which you will be responsible for all matters related to compliancy. You will be responsible for:

  • The maintenance of TCF’s and the communication of these changes to regulatory authorities
  • Keeping the clinical reports and post marketing surveillance/vigilance up-to-date
  • Monitoring and implement changes in QA and RA regulations
  • Overall monitoring of compliance, this includes documents, internal audits, external audits, CAPAs, etc.
  • Providing training in matrix maintenance, registration, and compliance
  • GDPR, data protection, data integrity

Requirements

We are looking for someone with the following skillset:

  • HBO level
  • Experience in 21CFR820 and ISO 13485 quality systems regulations
  • More than three years of experience in a QA/RA role at a medical devices company
  • Experience in life cycle management
  • Strong communication skills throughout all levels of the organisation
  • Fluent in English, written and spoken

Offer

This company offers a challenging job with high level of responsibility. The company has a relaxed work environment and offers a competitive salary and clear growth opportunities.

Application

If you are interested in this job, or in similar ones, please feel free to contact me directly.

Saskia Cepella
Consultant | Medical Devices

+31(0)6-13143973
+31(0)23-7548660
s.cepella@qtcrecruitment.com

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