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Regulatory ManagerSafecor Health, LLC • Columbus, Ohio, United States
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Regulatory Manager

Safecor Health, LLC
  • US
    Columbus, Ohio, United States
  • US
    Columbus, Ohio, United States
Postuler Maintenant

À propos

Regulatory Manager

Columbus OH - Columbus, OH 43204

Description

At Safecor Health, our mission is simple but powerful: help hospitals deliver medications safely, efficiently, and reliably.

As the nation's largest independently owned medication repackaging company, we support over 1,000 hospitals and healthcare systems across the country. Behind every unit-dose product is a team driven by our core values:

Care Commitment Excellence

We're looking for a Manager, Quality Assurance & Regulatory to lead critical quality and regulatory initiatives that ensure our products meet the highest standardsand ultimately protect patient safety.

The Opportunity

This is a high-impact leadership role responsible for shaping and maintaining FDA-compliant Quality Systems, driving regulatory strategy, and ensuring operational excellence across our organization.

You'll partner across teams, influence key decisions, and play a vital role in keeping Safecor in a constant state of compliance and readiness.

What You'll Do
  • Lead and maintain FDA-compliant Quality Systems (21 CFR Parts 210, 211, 820, 11, and 4)
  • Drive quality strategy, ensuring consistent production aligned with regulatory standards
  • Oversee vendor qualification programs, including audits and evaluations
  • Lead regulatory activities, including FDA/DEA interactions and field actions
  • Manage and enhance stability programs, including coordination with external labs
  • Provide quality oversight for contract packaging and outsourcing programs
  • Lead responses to FDA inspections, audits, and customer inquiries
  • Ensure labeling compliance and regulatory submissions (e.g., SPL, CARES Act reporting)
  • Oversee change control, deviations, CAPAs, and batch record review/release
  • Drive continuous improvement through regulatory intelligence and quality system enhancements
  • Partner cross-functionally and across sites to strengthen quality processes
What You Bring
  • Bachelor's degree in a scientific field (or equivalent experience)
  • 5+ years in pharmaceutical or medical device industry, with regulatory experience
  • Proven experience with FDA regulations and Quality Systems development
  • Leadership experience managing people and/or complex processes
  • Experience supporting or leading FDA inspections and audits
  • Strong knowledge of ICH guidelines, DEA regulations (preferred), and cGMP environments
  • Exceptional communication, organization, and problem-solving skills
  • A proactive, solutions-oriented mindset with a drive for continuous improvement
Why Safecor Health?

At Safecor, you're not just maintaining complianceyou're helping ensure that patients receive medications safely when they need them most.

You'll be part of a team that:

  • Cares deeply about patients and each other
  • Is committed to doing the right thing
  • Strives for excellence in everything we do
Ready to Make an Impact?

If you're passionate about quality, regulatory excellence, and making a real difference in healthcarewe'd love to hear from you.

  • Columbus, Ohio, United States

Compétences linguistiques

  • English
Avis aux utilisateurs

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