Global Regulatory Compliance Director

Your responsibilities will include: Provide strategic oversight and escalation support for the identification, documentation, communication, and remediation of significant quality system nonconformances against external regulations and internal SOPs/WIs. Provide executive leadership for external audit readiness and execution, including front room and back room governance, SME preparation, storyboard strategy, and site-level support for Global procedures. Deliver measurable process improvements through the VIP model and oversee year-over-year savings and productivity commitments against multimillion-dollar goals. Apply sound, systematic problem-solving and executive decision-making methodologies to identify, prioritize, communicate, and resolve complex quality and compliance issues. Minimum of Bachelor's degree in a relevant field Minimum of 10 years of Medical Device Quality Systems experience, including extensive experience leading or overseeing internal and/or external audit programs OR minimum of 10 years working within an external notified body or regulatory agency Strong understanding of regulations and standards applicable to the BSC Global Quality System (ISO 13485, 21 CFR 820, EU MDR, etc.). Demonstrated inclusive leadership skills with experience leading, developing, and influencing global teams and senior stakeholders Ability to travel up to 25% domestically and internationally Advanced degree Pharmaceutical or combination-product experience Digital product ownership, data analytics, audit technology, and/or IT project experience Strong executive presence, analytical capability, and communication skills High degree of integrity, professionalism, and the ability to establish credibility internally and externally, including with senior leaders and regulators High sense of urgency, strategic judgment, and commitment to execution in a complex global environment