As Quality & Compliance Sr. Director, you will lead the overall Quality function on site, ensuring full compliance with global regulatory standards while driving continuous improvement across the organization.
Your responsibilities will include:

• Leading and developing the Quality function (QA, QC, manufacturing quality support, validation, and on-site regulatory activities)
• Ensuring compliance with applicable standards and regulations, including ISO 13485, ISO 9001, FDA QSR (21 CFR 820), and MDSAP
• Acting as Person Responsible for Regulatory Compliance (PRRC) under EU MDR 2017/745
• Overseeing and continuously improving the Quality Management System (QMS)
• Driving key quality processes such as CAPA, change control, non-conformities, and process validation
• Leading regulatory inspections and audits (FDA, Notified Bodies, internal and external audits)
• Partnering cross-functionally with Operations, R&D, Clinical, a...