EMEA International Registration Manager

About Balt   

Our purpose is to improve the lives of 150,000 patients in 2026.   

 

Our story  

Balt is a rapidly growing pioneer in an exceptional field. For 45 years, Balt has been leading the way - collaborating with physicians and institutions to develop elegant medical devices.  Our products are being used by physicians across the world, and we have 13 offices in 11 countries – and counting.  

We introduced one of the first neurovascular intervention devices in 1977 and now offer the world's broadest portfolio of medical devices for stroke. As the premier global neurovascular platform always seeking to expand beyond boundaries, we are now bringing our innovation to the peripheral vascular space. 

We are proud of our mission, our people, and the incredible work we accomplish together as we empower physicians to save lives.  

 

Why Join Balt? Join a passionate team, dedicated to making a difference.   

• Working at Balt means giving meaning to your work! Pride is a strong part of our identity.   

• We are a close-knit team, with strong mission, vision and values that guide our day-to-day.   

• Recognition of work, respect, and our multicultural community are key aspects of the employee experience and contribute to our continued success.   

• No matter the country, we take care of you.   

Would you like to be part of our story? Don't hesitate, come and join us!  

 

Description: 

Driven by strong growth and rapid business expansion, our company is recruiting an EMEA International registration Manager to support regulatory strategy, ensure compliance with applicable regulations, and contribute to the successful development and commercialization of our products. 

 

Job Responsibilities: 

• Lead and manage activities regarding product registrations in EMEA region except CE marking 

• Write, analyze, and edit technical documents to support country-specific regulatory submissions in EMEA and compile submissions in a format consistent with applicable guidance documents. 

• Work with other departments and communicate the submission requirements when documents are needed for regulatory submission. 

• Maintain regulatory files. Maintain and update regulatory authorizations. Assure that appropriate maintenance of registrations occurs including renewals, device listings, site registrations, supplements for changes and annual reports.  

• Collaborate with distributors, UK authorized representative, CH authorized representative and answer their requests 

• Assist in preparing responses to regulatory authorities’ questions within assigned timelines. 

• Stay abreast of regulatory procedures, guidance documents, standards, and changes in regulatory climate. Perform gap assessment. 

• Support external audits, providing regulatory input to minimize potential for findings of non-compliance. 

• Participate in internal audit program 

• Assess and document regulatory impact of product design changes in jurisdictions where product is licensed  

• Update regulatory affairs files and trackers (submission files, licenses, and other documents related to EMEA international registrations) 

• Develop and maintain regulatory affairs procedures  

• Elaborate KPI and monitor international registrations in EMEA 

• Lead and mentor junior staff members 

 

 

Qualification Requirements: 

• Minimum of 4-5 years regulatory affairs and or quality assurance experience within a medical device organization  

• Documented training on current medical device standards and regulations is an asset (e.g. MDSAP, EU MDR, ISO 13485, etc.)  

• Scientific knowledge, must be able to digest complex data while keeping the big picture through good analytical skills  

• Excellent written and verbal communication skills with the ability to listen, articulate and advocate  

• Proactive, high performance, result oriented and manage projects with ethical integrity  

• Technical system skills (e.g. MS office applications, databases, efficient online research) 

• Master’s degree or country equivalent in Engineering, Science, related scientific discipline, or equivalent. Higher degree will be an advantage. RAPS certification will be an advantage. 

 

More information please go to www.baltgroup.com