Balt

www.baltgroup.com

1 Job

547 Employees

About the Company

We are Balt.

Physician-inspired innovations. Patient-focused solutions.

For more than 45 years, Balt has been leading the way - collaborating with physicians and institutions to develop elegant neurovascular solutions. As the premier global neurovascular platform, always seeking to expand beyond boundaries, we are now bringing our innovation to the peripheral vascular space.

We introduced the first neurovascular intervention device in 1977. Now, we offer the world's broadest portfolio of medical devices for ischemic and hemorrhagic stroke, as well as devices for peripheral embolization.

In 2015, we embarked on an ambitious journey and more than quintupled our revenue and workforce, and that was only the beginning. Now, Balt includes more than 950 talented team members at 16 sites/offices around the world.

Be a part of our future: www.baltgroup.com

Listed Jobs

Company Name: Balt
Job Title: EMEA International Registration Manager
Job Description: **Job Title** EMEA International Registration Manager **Role Summary** Lead and manage EMEA registration activities for medical devices, excluding CE marking, ensuring regulatory compliance and supporting product commercialization. **Expectations** - Maintain all regulatory submissions, authorisations, and documentation across EMEA - Collaborate cross‑functionally to gather and verify required data - Provide timely responses to regulatory authorities and external audits - Mentor junior staff and drive process improvement **Key Responsibilities** - Draft, review, and edit technical documents for country‑specific EMEA submissions. - Compile submissions in formats that align with applicable guidance. - Maintain regulatory files, authorisations, renewals, device listings, site registrations, and supplement submissions. - Manage relationships with distributors, UK and CH authorised representatives, responding to requests. - Prepare and deliver responses to regulatory authorities’ queries on time. - Monitor regulatory updates, conduct gap assessments, and evaluate impact of product design changes. - Support external and internal audits, providing regulatory input to minimise non‑compliance findings. - Update regulatory affairs trackers and develop standard operating procedures. - Establish and monitor KPIs for international registrations. - Lead and mentor junior team members. **Required Skills** - Minimum 4‑5 years regulatory affairs / quality assurance experience in medical device industry. - Deep knowledge of medical device regulation (MDSAP, EU MDR, ISO 13485, etc.). - Strong analytical ability to digest complex data and articulate insights. - Excellent written and verbal communication, listening, and advocacy skills. - Proactive, results‑oriented, project‑management competence, and ethical integrity. - Technical proficiency: MS Office, database usage, and online research. **Required Education & Certifications** - Master’s degree or equivalent in Engineering, Science, or related scientific discipline (Higher degree an advantage). - RAPS certification is an advantage, but not mandatory.