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.