Associate Regulatory Affairs Specialist

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.

As an Associate Regulatory Affairs Specialist, you will support Quality and Regulatory Compliance activities across the Benelux region. You will work with experienced Regulatory Affairs professionals to support post-market surveillance activities, field safety corrective actions, interactions with competent authorities, and quality management system processes. The role requires strong organizational skills, attention to detail, and effective collaboration with commercial and operational teams.

• →Coordinate the preparation, execution, and follow-up of field safety corrective actions and product hold activities within the Benelux region.
• →Manage inquiries from competent authorities related to vigilance activities and field safety corrective actions.
• →Advise sales teams on product complaint handling and product return processes in compliance with regulatory requirements and company procedures.
• →Support Quality Management System activities, including supplier management, distributor management, document control, and key performance indicator monitoring.
• →Monitor regulatory developments and support implementation of new regulatory requirements affecting the Benelux region.
• →Manage shared regulatory mailboxes and respond to internal, tender, and customer requests.
• →Support promotional and marketing activities by reviewing materials for regulatory compliance.
• →Collaborate with regional and global Quality and Regulatory teams on compliance initiatives and process improvements.

• Bachelor's degree with 0+ years of experience in Regulatory Affairs, Quality, Life Sciences, Biomedical Sciences, Healthcare, or a related field.
• Fluency in English and Dutch, both written and spoken.
• Advanced proficiency in Microsoft Office applications and database systems.
• Experience managing multiple priorities with strong organizational and administrative skills.
• Ability to work accurately with high attention to detail in a regulated environment.

• Knowledge of French or German.
• Knowledge of medical device regulations, post-market surveillance, or vigilance processes.
• Experience working within a Quality Management System certified to ISO 13485.
• Experience supporting regulatory, quality, or compliance activities in the healthcare or medical device industry.
• Proactive working style and ability to work effectively in a multicultural environment.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 

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