Regulatory Affairs Manager
Full Time Permanent Position
Belgium (Hybrid 50% onsite)
Competitive Salary, Company Car + Benefits Package
The Opportunity
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.
Key Responsibilities
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
* Maintain effective communication with Competent Authorities regarding Economic Operator activities.
* Drive process improvements across registration and compliance activities.
What We're Looking For
* 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)
* Strong knowledge of EU MDR and Economic Operator responsibilities.
* Experience managing registrations and regulatory compliance activities.
* Excellent project management and organisational skills.
* Strong communication skills with the ability to influence stakeholders across multiple functions.
* Previous people management or team leadership experience.
* Fluent English communication skills.
What's on Offer
* Leadership role with direct impact on regulatory strategy and business continuity.
* Exposure to complex international regulatory activities.
* Collaborative and supportive working environment.
* Strong opportunities for professional growth and development.
* Competitive salary and benefits package + Hybrid working.
For a confidential discussion or to learn more, please apply today or contact Connect Life Science directly.