R&d Quality Project Lead
vor 4 Wochen
Mandated by one of our client companies, we are looking for an **R&D Quality Project Lead.**
**General information**:
- Start date: ASAP
- End date: 15.12.2023
- Job location: Basel
- Languages: Fluent English is a must, German would be an asset.
**Your mission** Responsibilities**:
- Execution of the separation activities under responsibility of QA Medical Devices Changes in the medical device certifications for the company
- Establishment of processes and contracts for the new EU Authorised Representative at Novartis Pharmaceutical Manufacturing in Austria
- Preparation for the verification audits by Notified Body for the submitted changes
- Engagement with Notified Body for the issuance of the post separation certificates
- Participation in the relevant medical device workstreams
- Revisions of Quality agreements involving medical devices,
- Expert support for medical devices in interdependent WorkStreams and functional meetings.
**Your profile**
**Requirements**:
- Swiss and/or European nationality or an already existing and valid work permit for Switzerland.
- 5+ years of solid experience in medical devices, with an emphasis on Quality Assurance and Regulatory
- Preference for medical device experience in drug delivery systems, in the Pharma industry
- 3-5 years Experience in project management
- Experience with exchange with Notified Body
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