Scientific Data Specialist

Scientific Data Specialist

Occlutech

Jena, Germany

About the position

We are offering a position in the medical device sector with ambitious and passionate people building meaningful products for patients all over the world. Our work environment is agile and allowing for collaboration with smart people and knowledge sharing in cross functional teams. As a fast-growing organization, we provide ample room for development and our remote work policy allows for more flexibility for our employees.

Your work will focus on

• Prepare and manage clinical and regulatory documents (CER/CEP, PMCF, literature reviews, and study reports) in compliance with EU MDR, FDA, and other regulations;
• Support clinical research by writing protocols, reviewing study reports, and ensuring accurate safety reporting;
• Collaborate with internal teams to integrate quality and regulatory changes into clinical documentation;
• Interpret and present scientific data to support decision-making and optimize company potential;
• Maintain the integrity and accuracy of medical and regulatory information, including training staff when necessary;
• Assist in audits and establish strong relationships with external experts when required;
• Contribute to Occlutech’s Quality Management System (e.g., preparing SOPs) and perform other related tasks as needed.

We are looking for a candidate, who

• Has a medical degree or PhD with relevant experience leading to the ability to perform requirement independently;
• Has a minimum of 3 years’ experience in authoring clinical evaluation plans and reports, PMCF plans and reports, preferably with cardiovascular/high risk (Class III/IIb) medical devices;
• Possesses a strong knowledge of clinical study research and ethics compliance and cardiovascular medicine;
• Knows relevant government regulations, standards and guidelines as well as Medical Device Regulation (MDR), ISO;
• Knows computer applications, software’s for the execution of daily project operations;
• Has excellent analytical skills and ability to interpret scientific and clinical data;
• Is able to manage multiple projects and work collaboratively across departments;
• Communicated fluently in English (written and spoken); additional languages are a plus;
• Brings attention to detail and commitment to high-quality work;
• Is able to travel when it is needed.

Apply Now