Medline Industries, LP
Medline Industries, LP
Medline Industries, LP एक स्वास्थ्य सेवा कंपनी है, जो चिकित्सा उत्पादों के विनिर्माण, आपूर्ति श्रृंखला, लॉजिस्टिक्स और नैदानिक सहायता के क्षेत्र में काम करती है। इसके पोर्टफोलियो में 335,000 से अधिक चिकित्सा उत्पाद शामिल हैं, जिन्हें 2.8 करोड़ वर्ग फुट से अधिक के भंडारण क्षेत्र और लगभग 43,000 कर्मचारियों की वैश्विक टीम का समर्थन प्राप्त है। Medline सभी स्तरों पर स्वास्थ्य सेवा प्रदाताओं को सेवाएँ प्रदान करती है और उत्पादों की उपलब्धता, वितरण क्षमताओं, आपूर्ति श्रृंखला की मजबूती तथा नैदानिक विशेषज्ञता को एक साथ लाकर ग्राहकों को परिचालन, वित्तीय और रोगी देखभाल के परिणाम बेहतर बनाने में मदद करती है।

Principal Regulatory Affairs, Medical Devices – Remote Illinois

Lead global medical device submissions, approvals, and compliance strategies for Medline Industries. Manage regulatory projects, audits, labeling, and negotiations with the FDA and notified bodies.

विवरण

  • Create regulatory strategies for global product approvals and ongoing market compliance
  • Engage with regulatory authorities and provide input for future product development
  • Independently resolve regulatory issues and guide major projects
  • Define submission and filing requirements for clearance or approval in assigned markets
  • Identify and address factors that influence new product launch success and viability
  • Track regulatory updates and implement required compliance changes
  • Build and apply knowledge of harmonized standards
  • Explain regulatory requirements to internal and external customers
  • Advise on regulatory pathways, strategies, solutions, and next steps
  • Assess evidence against applicable regulations, guidance, and standards
  • Direct regulatory filings and coordinate internal and external stakeholders
  • Address non-conformances and regulatory questions with authorities
  • Lead product labeling and claims development, review, and substantiation
  • Oversee complex projects, schedules, technical deliverables, and cross-functional teams
  • Enhance regulatory and technical processes
  • Maintain compliance databases, records, and files
  • Lead audits and oversee post-audit corrective actions

आवश्यकताएँ

  • Bachelor’s degree in a life sciences field, engineering, medical technology, regulatory science, or a related discipline
  • At least five years of varied regulatory experience in the medical device industry
  • Strong global regulatory experience across pre-market and post-market activities
  • Experience preparing and managing regulatory submissions independently
  • Experience contributing to regulatory intelligence programs
  • Experience creating and executing regulatory strategies across multiple international markets
  • Ability to lead risk management and design and development activities
  • Extensive experience writing and submitting regulatory filings, including 510(k)s and CE Technical Files
  • Extensive experience communicating and negotiating with regulatory agencies, including the FDA and notified bodies
  • Ability to work independently and lead large-scale initiatives with significant business impact

लाभ

  • Competitive total rewards package
  • Continuing education and training
  • Health insurance
  • Life and disability insurance
  • 401(k) contributions
  • Paid time off
  • Employee Assistance Program
  • Employee Resource Groups
  • Employee Service Corp
  • Eligibility for bonuses and incentives
  • Career growth opportunities

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