We're Hiring: Regulatory Affairs Specialist (m/f/d) - Class III Medical Devices
📍 Location: Dieburg (on-site; up to 2 days remote after probation)
📅 Duration: Full time permanent
💶 Salary: €50,000 - 55,000 p.a. (depending on experience)
We're currently partnering with a leading manufacturer of Class III medical devices in their search for a Regulatory Affairs Specialist to join the team. The position is based at their main production and regulatory site, with flexible working arrangements available after the probation period.
🔹 Key Responsibilities
* Support EU MDR-related activities and contribute to international registrations, particularly in the Middle East, South America, and Asia.
* Maintain and update technical documentation in line with evolving global regulatory requirements.
* Collaborate with cross-functional teams to ensure compliance throughout the product lifecycle.
* Coordinate documentation and submissions as part of the broader global regulatory strategy.
* Contribute to the internal audit process; experience is a plus but not essential for this interim role.
🔹 Ideal Profile
* Degree in life sciences, engineering, or a related field.
* Around 2 years' experience in Regulatory Affairs, ideally with Class IIb or III medical devices.
* Knowledge of MDR and an interest in global regulatory frameworks.
* Strong communicator with excellent organisational and documentation skills.
* Fluent in German and English.
⚠️ Important Information - Only applicants with the right to work in Germany and are fluent in German can be considered.
💬 If you're looking for a role where you can make a real impact within a highly supportive and innovative regulatory team, we'd love to hear from you.
📩 Apply now or message me directly for more details.