Regulatory Affairs Manager Full Time Permanent Position
Connect Life Science are partnered with a global medical device organisation seeking a Regulatory Affairs Manager to join their European Regulatory Affairs team.
This is an excellent opportunity for an experienced Regulatory Affairs professional looking to take ownership of regulatory affairs activities across Europe while leading a team of 4 and driving continuous improvement initiatives.
You'll play a critical role in ensuring compliance with EU MDR requirements, supporting market access activities, interpreting regulatory changes, and acting as a key regulatory partner across the business.
If you're someone who enjoys combining hands-on regulatory work with leadership responsibilities in an international environment, we'd love to hear from you.
Team leadership
~ Lead, develop and manage 4 RA team members
Regulatory Affairs & EU MDR Expertise
Support submissions and compliance of new medical devices and maintain regulatory certificates and approvals of existing devices
Drive process improvements across registration and compliance activities.
Bachelor's degree or equivalent scientific, engineering, or healthcare-related qualification.
Proven Regulatory Affairs experience within Medical Devices (ideally with class IIb or class 3)
Experience managing registrations and regulatory compliance activities.
Previous people management or team leadership experience.
Fluent English communication skills.
Exposure to complex international regulatory activities.