Medical Writer Consultant (exernal) M/F/D - IVDR in Kremsmünster

Are you passionate about turning scientific data into clear, impactful documentation?

Join us in shaping the future of in vitro diagnostics. As a Medical Writer, you'll play a key role in ensuring that IVD products meet the highest scientific and regulatory standards. Working closely with cross‑functional experts, you'll transform complex scientific and clinical evidence into clear, compliant documentation that supports patient safety, regulatory compliance, and successful IVDR conformity activities.

If you thrive at the intersection of science, writing, and regulatory affairs, and enjoy supporting manufacturers in meeting evolving global regulatory requirements, we'd love to hear from you.

Key Responsibilities Author, review, and update regulatory and clinical documentation, including:

Performance Evaluation Reports (PER)

Analytical/Clinical Performance Study Plans and Reports

Literature Reviews and Evidence Evaluations

Clinical Evidence Summaries

Equivalence Assessments and Justifications

Data Review Summaries

Regulatory Confirmations and Compliance Statements

Conduct literature reviews and scientific data evaluations.

Analyze clinical, analytical, scientific, and post‑market surveillance data.

Support remediation projects and updates of legacy documentation to IVDR requirements.

Ensure consistency between clinical documentation, risk management, PMS activities, and technical documentation.

Provide expert recommendations on clinical evidence strategies and documentation approaches.

Support preparation for notified body reviews, audits, and regulatory submissions.

Collaborate effectively with internal stakeholders while independently managing project timelines and deliverables.

Qualifications Degree in Medicine, Life Sciences, Biology, Biomedical Sciences, Biotechnology, Pharmacy, or a related scientific discipline, while clinical laboratory, is considered a strong asset.

Minimum 5 years of experience in Medical Writing, Clinical Affairs, Regulatory Affairs, or Clinical Evaluation within the medical device and/or IVD industry.

Demonstrated experience authoring:

PEPs

PERs

Clinical Study Documentation (Analytical and Clinical Performance)

Strong knowledge of IVDR requirements.

Experience with literature evaluation and clinical evidence generation.

Strong scientific writing, critical appraisal, and data interpretation skills.

Excellent written and verbal communication skills in English.

Ability to manage multiple projects and meet timelines in a dynamic environment.

Experience working as an independent consultant or contractor.

Familiarity with:

IVDR (EU 2017/746)

ISO 20916

ISO 13485

ISO 14971

Familiarity with FDA guidance documents, 510(k), De Novo, PMA, IDE, and related clinical evidence requirements are advantageous.

Experience with low‑risk IVDs is advantageous.

Familiarity with MDR (EU 2017/745) and ISO 14155 is advantageous.

Experience with U.S. FDA regulatory requirements, submissions, and clinical documentation for IVDs is considered a strong asset.

Profile The ideal candidate is a self‑driven professional who can quickly understand complex technologies and independently develop high‑quality regulatory documentation with minimal supervision. Strong stakeholder management, communication skills, and the ability to work across multiple projects are essential.

Flexible consulting arrangement

Project‑based support with potential for long‑term collaboration

Immediate start preferred

Interested? We are looking for an experienced Medical Writer who combines scientific expertise with a thorough understanding of IVDR requirements. You bring a strong background in developing Clinical Evaluation and Performance Evaluation documentation and enjoy working in a fast‑paced consulting environment while contributing as an active member of a motivated and supportive team.

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