Freelance Consultant UKCA Regulatory Affairs (m/f/d)
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Ettlingen, Deutschland |
Freelance
Zu besetzendes Projekt: Freelance Consultant UKCA Regulatory Affairs (m/f/d)
Branche: MedizintechnikFähigkeiten: Regulatory Affairs,Change Control,Technical Documentation
Projektstart: 15.03.2022
Projektdauer: 31.12.2022
Auftragsvolumen: 1360 Stunde(n)
Einsatzort: Ettlingen, Deutschland
Aufgaben:
- Independent development of change submission packages for submission to the UK Approved Body, in order to obtain UKCA registration certificates for legacy products
- Independent development of NPI submission packages for submission to the UK Approved Body to obtain UKCA registration certificates
- Consulting during the review of labelling for compliance with UKCA regulations, as well as supporting QA on process development for the RA part in UKCA related processes
- Independent product registrations in the MHRA database
- Consult on cross-functional guidance on UKCA regulations and development of UKCA Tech Files and UKCA documentation for one of our European legal manufacturers
- Supporting the UK responsible person in the company on RA related activities
- Change impact assessments for UKCA requirements
- Education: Life science/engineering university degree preferred but also long-term Regulatory Affairs work in industry/Notified Bodies would be sufficient
- 3-5 years Regulatory Affairs background (product registrations) in medical devices preferred (all regions accepted) but also pharmaceutical or consumer regulatory background accepted
- Strong attention to detail and accurate work required, as well as willingness to do "hands on" Regulatory Affairs work
- Ability to work in a cross-functional, international, diverse team is desired
- English language knowledge is a must, more languages are advantageous
Referenznummer:
Branche:
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Kontakt
Annalisa Müller
a.mueller@aristo-group.com
+49 89 599 1827 300
11061
Medizintechnik
15.03.2022
31.12.2022
Freelance
