Senior 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.

A Day in the LifeAt Medtronic, we are inspired by our Mission to alleviate pain, restore health, and extend life. For more than 70 years, we have advanced purpose-driven healthcare technology that helps transform patient care. As a Senior Regulatory Affairs Specialist, you will play an important role in supporting regulatory compliance and enabling access to therapies across Romania, Moldova, and Bulgaria through strong partnership with internal and external stakeholders.
The Senior Regulatory Affairs Specialist is responsible for coordinating regulatory activities across Romania, Moldova, and Bulgaria to ensure compliance with applicable local and international regulations. This role supports both new product introductions and ongoing maintenance activities by partnering closely with regulatory authorities and cross-functional teams.

Responsibilities may include the following and other duties may be assigned:

• Coordinate and prepare documentation packages required for notifications, submissions, and license maintenance.
• Support regulatory requirements related to product importation and tender submissions.
• Manage MDD/MDR transition activities and associated regulatory documentation.
• Oversee post-market vigilance activities, including Field Safety Corrective Actions, in alignment with applicable requirements.
• Monitor regulatory changes and maintain awareness of evolving local and international procedures.
• Interact with competent authorities and other external stakeholders on regulatory matters.
• Partner with internal stakeholders to address regulatory issues, remove obstacles, and support timely execution of business priorities.
• Maintain accurate regulatory records and support audit-readiness through strong documentation practices.

Required Knowledge and Experience:

• Bachelor’s degree in Medicine, Pharmacy, Bioengineering, Chemistry, or a related field.
• Minimum of 3 years of relevant experience in regulatory affairs, preferably within the medical devices industry.
• Fluency in English, both written and spoken.
• Strong organizational, analytical, and time-management skills.
• Effective communication skills and the ability to work successfully with cross-functional teams in a matrixed environment.
• Customer-focused mindset with a proactive and solution-oriented approach.
• Positive team spirit and the ability to build collaborative relationships with internal and external stakeholders.
• Ability to adapt to changing regulatory requirements and manage multiple priorities with attention to detail.

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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Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses. 

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If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at [email protected]. 

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Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.  We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
 

Pay range / Rango salarial / Intervalo salarial /Fascia retributiva / Tranche de salaire / Gehaltsband / Salaribereik:  Romania: 200,000.00 RON - 300,000.00 RON | 
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).