Regulatory Manager responsible for developing global strategies for orthopedic implants at Acumed. Ensures compliance with regulatory applications and directs departmental projects.
About the role
- Director managing GxP Quality Systems to ensure compliant clinical supply operations. Collaborating with cross-functional teams and driving compliance strategy within global clinical supply.
Responsibilities
- Responsible for governing and advancing GCS’s global GxP Quality Systems.
- Ensure the organization executes clinical supply operations in a compliant, inspection‑ready, and risk‑based manner.
- Provide global‑level oversight and strategic direction across key compliance processes including deviations, CAPA, change control, documentation, training, audits/inspections, analytics, risk management, and safety.
- Partner closely with GCS functional areas and stakeholders to drive compliance strategy, QMS alignment, and performance improvement.
Requirements
- Bachelor’s degree in a Scientific, Engineering, or related field with 10+ years of relevant experience in a regulated GxP environment; or master’s degree with 8+ years of experience in compliance, quality, technical operations, or related disciplines.
- Experience leading or governing multiple GxP Quality Systems (e.g., deviations, CAPA, change control, documentation, training, audits/inspections, risk management, safety) is required.
- Demonstrated experience influencing cross-functional teams across global or multi-site organizations.
- Advanced technical expertise and the ability to lead enterprise-wide compliance systems.
- Ability to provide strategic oversight and governance for GxP processes across deviations, CAPA, change control, documentation, training, risk management, and safety.
- Deep understanding of GxP and ALCOA+ principles with the ability to embed quality and data integrity expectations into system and process design.
- Strong strategic thinking and decision-making capabilities.
Benefits
- medical,
- dental,
- vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays,
- vacation,
- compassionate and sick days
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