Expert Regulatory and Medical Writing (m/w/d)

Your challenge

• Creation, update, and review of regulatory documentation in English according to IVDR, including 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).
• Collaborate closely with clinical project management during trial conception to determine clinical data requirements.
• Coordinate with Quality Management and Research & Development regarding DHF-relevant documentation of clinical performance.
• Create clinical data summaries and confirmations for product registration, authority inquiries, and customer requests.
• Supervise and coordinate regular updates for IVD documentation in cooperation with the Post-Market Surveillance team.

Your profile

• Master’s degree in a life sciences-related field or equivalent, with relevant academic or vocational qualifications.
• Experience as a technical writer or similar role in a medical device or pharmaceutical company, demonstrating high attention to detail.
• Strong preference for experience with the regulatory landscape for IVDs and MDs.
• Experience with MD and/or IVD trials is advantageous but not mandatory.
• Validation experience is a plus but not required.
• Effective verbal and written communication skills in English with internal and external stakeholders, both locally and globally.
• Ability to work independently and reliably, managing multiple projects in a fast-paced, international environment.

Our offer

We offer an exciting and independent area of responsibility within a modern, collegial working environment. Due to legal requirements in Austria, the minimum gross salary for this position is EUR 59,781.96, as specified by the collective agreement for the chemical industry. Depending on your qualifications and experience, a higher overpayment may be possible.