Regulatory Affairs Specialist

1 maand geleden


Maastricht, Limburg, Nederland Medtronic Voltijd

Transformative Career Opportunity

We are seeking a highly skilled and innovative Regulatory Affairs Specialist to join our dynamic team at Medtronic. As a key member of our team, you will play a pivotal role in ensuring compliance with regulatory requirements and driving process improvements.

About the Role

As a Regulatory Affairs Specialist, you will be responsible for reviewing and enhancing QA structures, identifying areas for improvement, and implementing enhancements. You will also coordinate with cross-functional stakeholders to gather necessary information, provide regulatory guidance, and ensure alignment on project timelines and requirements.

Key Responsibilities

  • Review and enhance QA structures to ensure compliance with regulatory requirements
  • Coordinate with cross-functional stakeholders to gather necessary information and provide regulatory guidance
  • Maintain comprehensive documentation and evidence to support audit defensibility

Requirements

  • Strong understanding of the Medical Device Regulation (MDR)
  • Ability to navigate complex QA matrix structures
  • Experience in a similar industry or related field
  • Action-oriented and able to work independently
  • Excellent communication and interpersonal skills

What We Offer

We offer a competitive salary and benefits package, including flexible working environment, annual incentive plan, pension scheme, and training possibilities. We are committed to inclusion, diversity, and equity, and we strive to create a culture where all employees belong, are respected, and feel valued.



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