Location: Onsite (Beutenberg Campus in Jena, Germany)

Work model: Full time (40 hours)

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
A securejob in the medical device industry in a family-friendly working environment
An interesting work scope in a growing international company
Comprehensive onboarding and training plan in the ﬁrst 6 months
Good work-life balance through 30 days of vacation, ﬂexible working hours and hybrid, family-friendly working time models
Team building, employee, and company events
Healthy work culture with a fruit basket, tea, water and coﬀee as well as regular team sporting events

Ready to apply?

If you are passionate about scientific data and clinical research and want to make an impact in the medical device industry, we would love to hear from you!

Send your CV and cover letter to with the subject line "Scientific Data Specialist".

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Occlutech