QA/RA Compliance Specialist - Heerenveen
Function Group: Quality/RA / QA Officer
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.
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
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
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.
If you are interested in this job, or in similar ones, please feel free to contact me directly.
Consultant | Medical Devices
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