Do you recognize yourself in below skills & competences:
- Scientific Literacy: strong foundation in life sciences, biomedical sciences, or medicine; able to understand and accurately interpret complex scientific and clinical data.
- Knowledge of regulatory guidelines: familiarity with applicable regulatory guidelines (e.g., EU MDR, IVDR, FDA, MDCG guidance documents) and Good Clinical Practices (GCP).
- Data Interpretation: Ability to interpret, synthesize and present clinical and scientific data clearly and concisely, without unnecessary complexity.
- Time Management & Prioritization: Capable of handling multiple projects and deadlines efficiently, with strong organizational skills.
- Attention to Detail: Strong focus on accuracy, consistency, grammar, and data integrity in all written materials while maintaining oversight of the bigger picture.
- Adaptability: Comfortable working in dynamic environments, managing shifting priorities, evolving project scopes and cross-functional collaborations.
- Self-Motivated & Independent Worker: Proactive and reliable, with the ability to work independently and contribute meaningfully to team efforts.
In this role, you will have the opportunity to:
- Develop, write and edit regulatory documents and technical documentation for medical devices and IVDs, such as Clinical Evaluations Plans and Reports, Performance Evaluation Plans and Reports.
- Perform MDR or IVDR-compliant systematic literature reviews.
- Develop, write and edit documentation for clinical studies for medical devices and IVDs, such as protocols, informed consent forms, and study reports.
- Write scientific publications and communication documents related to medical devices and IVDs.
- Ensure all documents are compliant with relevant regulations, industry standards, client-specific requirements and internal procedures.
- Collaborate closely with cross-functional teams and clients to gather and interpret input for the documents and ensure alignment on regulatory strategy.
- Deliver within the agreed timelines and budget.
- Stay updated on regulatory changes and medical writing best practices.
The essential requirements for the job include:
- Master or advanced degree in a scientific, medical, or life sciences field.
- Previous experience in a medical writing role or clinical operations role in the medical device or IVD field and/or willingness to follow medical writing training.
- Proficiency in Microsoft Office Suite and reference management software.
- Excellent written and verbal communication skills in English.
