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 a Regulatory Affairs Specialist, you will support regulatory compliance and market access activities for medical devices across Romania, Moldova, and Bulgaria. The role is responsible for coordinating product registrations, maintaining regulatory documentation, supporting post-market activities, and collaborating with internal and external stakeholders to ensure compliance with applicable regulatory requirements.

• →Prepare and maintain regulatory documentation for product registrations, notifications, submissions, and license renewals.
• →Support regulatory requirements associated with product importation and tender participation.
• →Coordinate Medical Device Directive (MDD) to Medical Device Regulation (MDR) transition activities and maintain related documentation.
• →Support post-market surveillance and vigilance activities, including Field Safety Corrective Actions, in accordance with local and international requirements.
• →Monitor regulatory changes and assess potential impacts on products and business activities.
• →Interact with competent authorities, distributors, and external stakeholders regarding regulatory submissions and compliance matters.
• →Collaborate with cross-functional teams to resolve regulatory issues and support product availability in assigned markets.
• →Maintain accurate regulatory records and documentation to support inspections, audits, and ongoing compliance.

• Bachelor's degree in Medicine, Pharmacy, Bioengineering, Chemistry, Life Sciences, or a related scientific discipline AND 1+ years of medical device regulatory affairs experience.
• Fluent English communication skills, written and spoken.
• Experience supporting regulatory submissions, registrations, or product lifecycle maintenance activities.
• Knowledge of medical device regulations and regulatory processes.
• Proficiency with Microsoft Office applications and regulatory documentation management.

• Experience supporting regulatory activities in Romania, Moldova, Bulgaria, or other Eastern European markets.
• Knowledge of European Medical Device Regulation (EU MDR) requirements.
• Experience with product registration, importation, and tender-related regulatory processes.
• Experience supporting post-market surveillance, vigilance reporting, or Field Safety Corrective Actions.
• Experience working in a multinational, matrixed medical device organization.

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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