Regulatory Manager

Safecor Health•Columbus, OH

1d•Onsite

About The Position

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 standards—and ultimately protect patient safety. 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.

Requirements

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

Nice To Haves

DEA regulations

Responsibilities

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