Scientific Data Specialist (m/w/d)
Full time (40 hours)
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.
Prepare and manage clinical and regulatory documents (CER/CEP, PMCF, literature reviews, and study reports) in compliance with EU MDR, FDA, and other regulations
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
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); Is able to travel when it is needed
Our benefits
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
Companywide Mentoring program
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
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!
com with the subject line "Scientific Data Specialist".