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.