LogoFresh Jobs Ahead
Medline Industries, LP
Medline Industries, LP
Asistență medicalăIndustria prelucrătoareLogistică
Medline Industries, LP este o companie din domeniul asistenței medicale, cu activități în producția de produse medicale, lanțul de aprovizionare, logistică și asistență clinică. Portofoliul său include peste 335.000 de produse medicale, susținute de mai mult de 28 de milioane de picioare pătrate de spații de depozitare și de o forță de muncă globală de aproximativ 43.000 de angajați. Medline deservește furnizorii de servicii medicale în toate punctele de îngrijire, combinând accesul la produse, capacitățile de distribuție, reziliența lanțului de aprovizionare și expertiza clinică pentru a-i ajuta pe clienți să își îmbunătățească rezultatele operaționale și financiare, precum și rezultatele îngrijirii pacienților.
LinkedIn
Locurile de muncă ale companiei

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.

USStatele Unite ale AmericiiILIllinois
116.000 $ – 174.000 $ / an
RemoteNormă întreagăLiderLimbă Obligatorie: englezăConformitate

Descriere

  • 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

Cerințe

  • 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

Beneficii

  • 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

Locuri de muncă similare