Regulatory Manager
Safecor Health, Columbus, OH, United States
Mission
At Safecor Health, our mission is simple but powerful: help hospitals deliver medications safely, efficiently, and reliably.
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 the 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 compliance—you’re helping ensure that patients receive medications safely when they need them most.
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 healthcare, we’d love to hear from you.
#J-18808-Ljbffr
At Safecor Health, our mission is simple but powerful: help hospitals deliver medications safely, efficiently, and reliably.
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 the 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 compliance—you’re helping ensure that patients receive medications safely when they need them most.
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 healthcare, we’d love to hear from you.
#J-18808-Ljbffr