Job Description

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 Life

The Regulatory Affairs function supports market access and regulatory compliance activities for Medtronic’s medical device portfolio across Romania, Moldova, and Bulgaria. The team partners closely with regulatory authorities, distributors, commercial teams, quality, supply chain, and global regulatory functions to ensure products meet applicable local and international regulatory requirements throughout their lifecycle.

This position is based in Romania and operates in a flexible work environment. The role supports regulatory activities across multiple product portfolios and countries, providing exposure to a broad range of medical device regulations, registration processes, and post-market obligations.

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.

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

• 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.

Required Qualifications

• 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.

Preferred Qualifications

• 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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Recruitment Fraud Alert

We are aware of phishing scams targeting job seekers. Please keep the following in mind:

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

Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate.

If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments.

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 AskHR@medtronic.com.

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: 139,200.00 RON - 208,800.00 RON |

The final salary within this range will be determined based on objective, job-related criteria, including relevant experience, skills and qualifications, in accordance with our compensation framework.

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This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).