Retour aux offres d'emplois

Regulatory Operations Engineer – F/H

Présentation société

Balt est un pionnier en pleine croissance dans un domaine exceptionnel. Depuis 45 ans, Balt ouvre la voie – en collaborant avec des médecins et des institutions pour développer des dispositifs médicaux hauts de gamme. Nos produits sont utilisés par des médecins du monde entier. Nous avons 13 bureaux dans 11 pays – et ce n’est que le début.

Nous avons introduit l\’un des premiers dispositifs d\’intervention neurovasculaire en 1977 et offrons aujourd\’hui le plus large portefeuille de dispositifs médicaux au monde pour les accidents vasculaires cérébraux. En tant que première plateforme neurovasculaire mondiale cherchant toujours à dépasser les frontières, nous apportons maintenant notre innovation à l’espace vasculaire périphérique.

Nous sommes fiers de notre mission, de nos employés et du travail incroyable que nous accomplissons ensemble pour permettre aux médecins de sauver des vies.

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:

As part of the Regulatory Affairs team and reporting to the EMEA & LATAM Director of Regulatory Affairs,

Job Responsibilities:

• Work with other departments and communicate regulatory requirements
• 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 CRQ, CO, QP
• Provide regulatory support to CAPA, complaints, FSN, recall management
• Support other projects as required
• Identify areas for improvement and streamline regulatory operations to enhance productivity and compliance.
• Provide training on regulatory requirements and best practices to internal teams.
• Prepare the monthly update of the authorized distribution list and its implementation in SAGE
• Manage the special release requests
• Provide support for product registrations (apostille, notarization…)
• Provide support to fulfill obligations of legal manufacturer and authorized representative per article 10 and 11 of the EU 2017-745 regulation (MDR) respectively.
• Provide support to UK and CH authorized representatives
• Carry out verifications required as importer and distributor per article 13 and 14 of the MDR
• Provide support to manufacturing department (daily manufacturing meeting)
• Update databases (Eudamed, FMPS..)
• Elaborate and follow KPI for regulatory affairs process
• Review communication materials for compliance
• Define label content

Descriptif du profil

Qualification Requirements:

• 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
• 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)

Postuler

Recrutement
recrutement@baltgroup.com

https://baltgroup.com/