Suchergebnisse: 8 Stellenangebote
...least 5 years of experience in a comparable role.
Experience with EU and FDA medical device regulation and/or local authorities (SwissMedic, BfArM)
Proven experience with reading and interpreting device diagnostics and/or troubleshooting mechanical ventilation...
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Lehrstelle
Remote job
...and approve C&Q documents of GMP systems as well as related changes and deviations.
• Support audits and regulatory inspections (Swissmedic, FDA, etc.).
• Provide leadership and guidance to project team members on C&Q strategy and issues.
• Ensure that decisions...
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Homeoffice
Remote job
...seeking a detail-oriented Regulatory Affairs Manager and a strategic thinker, to lead registration tasks and ensure compliance with Swissmedic regulations.
Your main responsibilities will include:
Development and assessment of regulatory strategies for development...
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...Unit and will support the Project Team for the operational readiness of a fill-finish aseptic line project in Stein from PQ until Swissmedic Inspection. In order to support the strategic investments of the company in Stein, Global Quality Engineering is looking for an...
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Vollzeit
Swisslinx
Aarau AG
Vor 19 Tagen
...supplier management process as outlined in the SOPs (including supplier audits)
Ø Maintaining QA activities in compliance with Swissmedic, EU, and FDA (if applicable) regulations across therapeutic areas
Ø Participating in the collaboration and negotiations of Quality...
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Flexible Arbeitszeit
...affairs matters for the assigned indication group and will act as an interface between global Regulatory Affairs departments and Swissmedic to obtain new marketing authorizations as well product lifecycle maintenance, support new product launches, ensure regulatory compliance...
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Vollzeit
...3rd party (external) audits from Notified Bodies and regulatory bodies or Competent Authorities (notified body, ETL-certification, Swissmedic)
• Conduct root cause analyses and define and implement CAPAs
• Perform the corrective measures resulting from audits
• Perform...
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...and cardiovascular research. The group facilities are GLP (Good Laboratory Practice) accredited by the Swiss regulatory agency, Swissmedic, which has greatly facilitated clinical translation and registration processes for medical devices and biologics. The MSRU also provides...
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Universität Zürich
Zürich ZH
Vor 28 Tagen
