Medtronic
Medtronic
Medtronic एक वैश्विक स्वास्थ्य प्रौद्योगिकी और विनिर्माण कंपनी है, जो जटिल चिकित्सा स्थितियों के लिए समाधान विकसित करती है। इसके कार्य में बड़े, अंतरराष्ट्रीय दलों और स्वास्थ्यसेवा पेशेवरों के साथ घनिष्ठ सहयोग शामिल है, ताकि उपचार, चिकित्सा पद्धतियों और चिकित्सा प्रौद्योगिकी तक पहुंच में सुधार किया जा सके। 150 से अधिक देशों में 95,000 से ज्यादा कर्मचारियों के साथ, Medtronic रोगी देखभाल को आगे बढ़ाने पर ध्यान केंद्रित करती है और अपने संचालन में समावेशन, विविधता, समानता तथा टिकाऊ प्रथाओं को बढ़ावा देती है।

Associate Regulatory Affairs Specialist - Eindhoven, Netherlands (Hybrid)

Support Medtronic’s Benelux medical-device compliance program through vigilance, safety actions, quality systems, and regulatory coordination. Partner with regional teams and authorities to maintain compliant post-market and regulatory processes.

विवरण

  • Coordinate field safety corrective actions and product holds across the Benelux region, from preparation through follow-up.
  • Handle competent-authority inquiries concerning vigilance activities and field safety corrective actions.
  • Guide sales teams on compliant product complaint handling and product return procedures.
  • Contribute to Quality Management System activities covering suppliers, distributors, document control, and KPI monitoring.
  • Track regulatory changes and help implement new requirements affecting the Benelux region.
  • Manage shared regulatory inboxes and answer internal, tender, and customer requests.
  • Review promotional and marketing materials for regulatory compliance.
  • Work with regional and global Quality and Regulatory teams on compliance initiatives and process improvements.
  • Support post-market surveillance, safety actions, authority interactions, and Quality Management System processes across the Benelux region.
  • Coordinate with commercial, quality, regulatory, and operational stakeholders.

आवश्यकताएँ

  • Bachelor’s degree with at least 0 years of experience in Regulatory Affairs, Quality, Life Sciences, Biomedical Sciences, Healthcare, or a related field.
  • Fluent written and spoken English and Dutch.
  • Advanced proficiency with Microsoft Office applications and database systems.
  • Demonstrated ability to manage competing priorities with strong organizational and administrative skills.
  • High accuracy and attention to detail when working in a regulated environment.
  • French or German language knowledge is preferred.
  • Knowledge of medical-device regulations, post-market surveillance, or vigilance processes is preferred.
  • Experience with an ISO 13485-certified Quality Management System is preferred.
  • Experience supporting regulatory, quality, or compliance work in healthcare or medical devices is preferred.
  • A proactive approach and effectiveness in multicultural working environments are preferred.

लाभ

  • Flexible work arrangement.
  • Competitive salary with a flexible benefits package.
  • Broad benefits, resources, and competitive compensation plans supporting employees across career and life stages.
  • Short-term incentive through the Medtronic Incentive Plan (MIP).

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