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Senior Regulatory Affairs Specialist
il y a 1 semaine
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.
