We're Hiring: Interim Regulatory Affairs Specialist (m/f/d) - Class III Medical Devices
📍 Location: Germany (on-site; up to 2 days remote after probation)
📅 Duration: Minimum 12 months (maternity cover, up to 18 months possible)
💶 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 an Interim Regulatory Affairs Specialist to join the team on a 12-18 month maternity cover contract. The position is based at their main production and regulatory site near Frankfurt, 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 3 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
* This is a temporary maternity cover position, with a minimum contract of 12 months, and potential to extend to 18 months.
* Only applicants with the right to work in Germany 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.