Expert Regulatory Writing (m/w/d)

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Yes

Job Reference:

46dce25c322e

Job Views:

5

Posted:

14.03.2025

Expiry Date:

28.04.2025

Job Description:

• 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 in a fast-paced and changing international environment.

Our Offer

We 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.