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Regulatory affairs manager - remote

Darmstadt
iO Associates - UK/EU
Manager
Inserat online seit: Veröffentlicht vor 15 Std.
Beschreibung

We're Hiring: Interim Regulatory Affairs Specialist (m/f/d) - Class III Medical Devices

&##up to 2 days remote after probation)
&##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.
&##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.
experience is a plus but not essential for this interim role.
&##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.
Fluent in German and English.
⚠️

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