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Medtronic Senior Regulatory Affairs Specialist in Belgium

Careers that Change Lives

Are you ready to join a dynamic and energetic team? We're seeking a passionate and innovative professional to join us, and collaborate with both subject matter experts (SMEs) and seasoned project/process improvement colleagues. In our small but mighty team, your ideas and contributions won't just be heard—they'll drive meaningful change and growth. If you're eager to blend your skills with a team, drive impactful change within a collaborative and innovative environment, and value creativity, efficiency, and excellence, we want to hear from you!

We are looking for a QRA professional with understanding of the MDR and a knack for navigating complex matrix QA structures. Your contribution will be pivotal in ensuring compliance. The ideal candidate will also show a keen interest in process improvements, contributing to the continuous enhancement of our operations.

A Day in the Life (Initially)

• Review & Enhance QA Structure: Conduct a thorough review of existing MDR QA regional structures, identifying areas for improvement, and implementing enhancements.

• Review & Enhance the risk management plan for Economic Operators, identifying potential risks & mitigations.

• Coordinate with Cross-Functional stakeholders to gather necessary information, provide regulatory guidance, and ensure alignment on project timelines and requirements.

• Maintain comprehensive documentation and evidence to support audit defensibility, ensuring that processes and procedures can withstand regulatory scrutiny and audits.

Must Haves

• Solid understanding of the Medical Device Regulation (MDR)

• Systems Agility

• Ability to navigate complex QA matrix structures

• Experience in a similar industry or related field

• Action oriented

• Solid command of English

• Excellent Communication and interpersonal skills

• Flexibility and adaptability in a fast-paced environment

• Ability to work independently and take initiative

Nice to Haves

• Knowledge of other regulatory requirements

• Proficiency with relevant software and tools

• Familiarity with agile methodologies or other project management frameworks

We Offer

We offer a competitive salary and benefits package to all our employees:

• Flexible working environment

• Annual Incentive Plan % depending on company results

• Pension scheme and group discount on healthcare insurance

• Training possibilities via Cornerstone/Skills Lab

• Employee Assistance Program and Recognize! (our global recognition program)

Our Commitment

Our unwavering commitment to inclusion, diversity, and equity (ID&E) means zero barriers to opportunity within Medtronic and a culture where all employees belong, are respected, and feel valued for who they are and the life experiences they contribute. We know equity starts beyond our workplace, and we must play a role in addressing systemic inequities in our communities if we hope to have long-term sustainable impact. Anchored in our Mission, we continue to drive ID&E forward both to enhance the well-being of Medtronic employees and to accelerate innovation that brings our lifesaving technologies to more people in more places around the world.

About Medtronic

Bold thinking. Bolder actions. We are Medtronic.

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000+ passionate people. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world.

In everything we do, we are engineering the extraordinary .

Your Answer

Is this the position you were waiting for? Then please apply directly via the apply button!

#LI-Hybrid

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

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