Job Title: Regulatory Affairs Specialist
Location: Hybrid, Zagreb, Croatia
Time Type: Full Time
Posted On: 5 Days Ago
Job Requisition ID: R24557
Job Description
At Medtronic, begin a career of purpose-driven innovation in healthcare technology. We are committed to improving access and equity in healthcare, supporting patients and partners with high-quality solutions that truly make a difference.
A Day in the Life
For over 70 years, Medtronic has inspired the extraordinary. As a Regulatory Affairs Specialist, you will oversee product regulatory activities across Albania, Bosnia & Herzegovina, Croatia, Kosovo, and Slovenia, ensuring compliance with international and local regulations. Your work will involve planning, coordination, and execution of regulatory strategies for both new product introductions and lifecycle management of existing products.
Key Responsibilities
Collaborate with global/regional teams to create and maintain submission plans for new launches, renewals, and product changes aligned with business strategy.
Track submission progress using KPIs and internal systems.
Coordinate and prepare documentation packages for regulatory submissions including new registrations, renewals, changes, and notifications.
Support regulatory requirements for importation processes and tender submissions.
Manage MDD to MDR transition activities in compliance with evolving EU regulations.
Conduct post-marketing vigilance, including managing Field Safety Corrective Actions.
Monitor and remain updated on local and international regulatory changes.
Maintain communication with competent authorities and relevant external stakeholders.
Operate and maintain internal regulatory tracking and control systems.
Required Qualifications
Bachelor’s degree in Medicine, Pharmacy, Bioengineering, Chemistry, or a related field.
Minimum 2 years of regulatory affairs experience, preferably in the medical devices sector.
Proficient in English (spoken and written).
High motivation with a strong focus on customer needs.
Excellent organizational and communication skills.
Demonstrated team spirit and collaborative mindset.
Physical Job Requirements
This description is representative of the duties and responsibilities commonly assigned to this role. It is not intended to be a complete or exhaustive list of all responsibilities or skills required.
Benefits & Compensation
Competitive salary and flexible benefits package.
Comprehensive resources and support for every stage of life and career.
Recognition and reward programs aligned with employee contributions and success.
About Medtronic
As a global healthcare technology leader, Medtronic boldly tackles the most urgent health challenges. Our mission — to alleviate pain, restore health, and extend life — unites over 95,000 employees globally. From innovation labs to manufacturing lines, we engineer the extraordinary by translating bold ideas into meaningful impact.
Gujarat :
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