Expert Regulatory Writing (m/w/d)

Job title:

Expert Regulatory Writing (m/w/d)

Company

Greiner

Job description

Your challenge

• Creation and/or update as well as review of regulatory documentation in English according to IVDR incl. PEP, PER, APR, CPR and SVR for existing and new products
• Perform Gap-analysis of missing clinical data to support product-specific intended use of existing products (EU, US, rest of the world)
• Close cooperation with and strong support of clinical project management during trial conception regarding clinical data required
• Close cooperation with Quality Management and Research & Development regarding DHF-relevant documentation of clinical performance
• Creation of clinical data summaries and confirmations for product registration, enquiries from the authorities and customer requests
• Supervision and coordination of regular updates for IVD documentation in cooperation with Post-Market Surveillance team

Your Profile

• Master’s degree in a life sciences-related field or equivalent and relevant formal academic / vocational qualification.
• Experience as a technical writer or equivalent for a medical device or pharmaceutical company demonstrating high attention to detail
• Experience with regulatory landscape for IVDs and MDs is strongly preferred
• Experience with MD and/or IVD trials is preferred but not required
• Experience in validation preferred, but not required
• Effective and appropriate verbal and written communication in English with internal and external stakeholders, locally and globally
• Ability to work independently and reliably in managing multiple project tasks and priorities and in a fast-paced and changing international environment

Our OfferWe offer you an exciting and independent area of responsibility in a modern and collegial working environment. Due to legal requirements in Austria, we are obligated to disclose the minimum gross salary for the position as defined by the collective agreement which amounts to EUR 58.200,00 (collective agreement for the chemical industry). Depending on your qualifications and professional experience, you may be eligible for a significant overpayment.Wir stehen als Arbeitgeber für Chancengleichheit und berücksichtigen alle qualifizierten Bewerber:innen unabhängig von Merkmalen wie Geschlecht, Alter, Hintergrund, sozialem Status, sexueller Orientierung, Religion sowie geistigen und körperlichen Fähigkeiten. Wir haben uns das Ziel gesetzt, den Frauenanteil in Führungs- und Expertenfunktionen zu erhöhen und ermutigen daher qualifizierte Frauen sich zu bewerben.Job ID: 2521Über Greiner Bio-OneGreiner Bio-One ist ein Zuhause.Für Visionäre, die sich mit Power und Ideen einbringen, für Team-Player, die Wissen teilen und neue Denkweisen zulassen, für Menschen, die nach Exzellenz streben. Greiner Bio-One hat offene Türen für Könner, Macher und verborgene Talente, die in der Gesundheit Großes bewegen wollen.Wir haben Zukunft im Blut!

Expected salary

Location

Kremsmünster, Oberösterreich

Job date

Fri, 14 Feb 2025 08:51:42 GMT

To help us track our recruitment effort, please indicate in your email/cover letter where (jobsjobs.org) you saw this job posting.