16. May 2020
JOIN OUR TEAM! WE ARE HIRING
Effectum Medical is a young company that is breaking new ground in the areas of quality management and regulatory affairs in the medical device industry. Our vision is to facilitate and accelerate medical device product innovation by offering an affordable, outsourced quality management system (QMS) and legal manufacturing. Our customers are start-ups, as well as global medical device manufacturers.
To further grow our company, we are looking for a
Project Manager Regulatory Affairs (60-100%)
to join our team.
In this position
• You will coach start-ups and project teams from global players on their regulatory strategy for EU & FDA registration and therefore play a key role in making their project a success.
• You will support our customers in bringing the technical documentation to the point where they can obtain the CE mark (or FDA approval). Depending on the customer, you will also write specific parts of the technical documentation yourself.
• You will suggest and implement improvements to our QMS and processes.
• Your main focus will be projects in medical software and medical devices with embedded software of all risk classes.
• successfully lead development projects for medical software and obtained certification.
• at least 2-3 years of professional experience in regulatory affairs in the medical device industry.
• knowledge of ISO 13485, MDD (MDR), QSR 21 CFR Part 820, IEC 62304, IEC 60601-1, and the certification processes for medical devices in Europe and the USA for medical software and medical devices with embedded software.
• ideally, an education in software engineering, however a technical flair is a must.
• a customer focused approach to coordinate and supervise stakeholders.
• excellent knowledge of English, written and spoken, and good conversational skills in German.
• the possibility of working in a motivated team with a common goal – accelerating innovation in the medical devices industry.
• flexibility – our offices are located in Olten, partially working from home is possible.
• the ability to actively shape and further develop the company with us to reach our common goal.
• Personal development opportunities in a growing company.
Do you share our vision? If the answer is “YES!” we are looking forward to getting to know you. Please send your application to monika.truempler(at)effectummedical.com