Regulatory Affairs Expert

3 weken geleden


Maastricht, Limburg, Nederland Medtronic Voltijd

Careers that Change Lives

Medtronic is seeking a highly skilled and innovative professional to join our dynamic and energetic team. We are looking for a QRA specialist with a solid understanding of the MDR and a knack for navigating complex matrix QA structures.

A Day in the Life

• Review and enhance QA structure: Conduct a thorough review of existing MDR QA regional structures, identifying areas for improvement and implementing enhancements.
• Review and enhance the risk management plan for Economic Operators, identifying potential risks and 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.

Requirements

• Solid understanding of the Medical Device Regulation (MDR)
• 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

What We Offer

We offer a competitive salary and benefits package to all our employees, including a flexible working environment, annual incentive plan, pension scheme, group discount on healthcare insurance, training possibilities, employee assistance program, and a global recognition program.


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