Employee Post Market Surveillance

We are MIETHKE, a globally active, medium-sized medical technology company based in Potsdam. As a technology leader in the field of neurosurgical implants, we develop and manufacture highly specialized solutions for the drainage of cerebrospinal fluid - with precision, innovative strength and responsibility for our patients suffering from hydrocephalus. Our particularly high level of vertical integration is a key success factor.

As part of our Clinical Scientific Affairs team, you will be responsible for the effective implementation of the post-market surveillance process for the continuous monitoring of the safety, quality, and performance of our medical devices worldwide, taking into account international regulatory requirements.

Be a part of our versatile team: Do you want to shape things, take on responsibility and work in an environment of equals? Then you've come to the right place. We are looking for a committed individual with analytical acumen, a structured way of thinking and a desire for responsibility.

And: diversity, appreciation and tolerance are part of our culture - we would be delighted if this also corresponds to your core values.

• You are responsible for implementing the post-market surveillance process in accordance with international regulatory requirements (e.g., EU MDR, FDA 21 CFR Part 822, ISO 13485).
• You will create, maintain, and update PMS documents for global regulatory purposes, e.g., Periodic Safety Update Reports (PSUR) or FDA Postmarket Surveillance Reports.
• You will coordinate interfaces with clinical evaluation, risk management, and other departments to ensure consistent and reliable statements throughout the product life cycle.
• You will research relevant data sources, e.g., international databases, registry data, internal market data, and evaluate them in a structured manner.
• You will prepare and support internal and external audits and inspections in the PMS area of responsibility.

• Completed degree in natural sciences, engineering, or medicine desirable
• Alternatively: completed vocational training in a medical, technical, or regulatory environment, or several years of relevant professional experience in post-market surveillance, regulatory affairs, or quality management
• Knowledge of regulatory requirements in the field of PMS (e.g., EU MDR, ISO 13485, ISO/TR 20416, FDA 21 CFR, TGA, MHRA, MDSAP)
• Initial experience in the creation and maintenance of PMS documents (e.g., PMS plan, PMS report, PSUR, SSCP)
• Very good written English skills and good German skills
• Structured and careful way of working, as well as independence, reliability, and interest in learning about new regulatory topics

• a working environment in an innovative, medium-sized company with over 250 employees and interesting and varied tasks
• family-friendly and flexible working time models, trust-based working hours and a workplace, where we can be ourselve
• an employment relationship (fulltime) initially limited to two years with a clear interest in a permanent contract in a secure economic situation
• the possibility of a company pension scheme, further qualification through the opportunity to participate in further training events
• sporting activities and team events as well as coffee specialties, tea and water at any time, but also much more