Director, QARA European MSM & CEE

DePuy Synthes is recruiting foraDirector QARA European MSM & CEE this Hybrid position will be based in Warsaw Masovian (Poland). Alternate Hybrid locations may be considered in Amersfoort or Utrecht (Netherlands) Diegem (Belgium) Oberdorf or Zuchwil (Switzerland).

Job Overview

TheDirectorQARAEuropean MSM & CEEis responsible forproviding senior leadership for Quality Assurance and Regulatory Affairs across European MSM and Central & Eastern Europe (CEE) markets within theInternationalQARAorganization. This role ensures consistent regulatory compliance quality system execution and effective market access across diverse and complex markets. The position hassignificantstrategic impact by shaping regional QARA strategy enabling sustainable business growth and serving as a key partner to Commercial Supply Chain and Global QARA leadership.

Key Responsibilities

• Provide strategic leadership for Quality Assurance and Regulatory Affairs across European MSM and CEE markets.

• Ensure compliance with regional and countryspecific regulatory requirements EU MDR internal policies and quality system standards.

• Oversee regulatory strategy submissions and lifecycle management activities across the assigned markets.

• Serve as the senior QARA escalation point for European MSM & CEE Local Market Support.

• Partner with Commercial Supply Chain Quality and Global Regulatory teams to support compliant product distribution and business initiatives.

• Monitor regulatory and quality trends assess risks and drive mitigation strategies across the region.

• Lead audit andinspectionreadiness including internal audits external audits and health authority inspections.

• Lead coach and develop regional QARA leaders and teams fostering a strong quality and compliance culture.

• Ensuring proactive engagement and shaping of regional policy initiatives that are critical to business strategy continuity and growth.

Qualifications

Education:

• Bachelors degree in Regulatory Affairs Quality Life Sciences Engineering ora relateddiscipline (required).

• Advanced degree in a scientific regulatory or business field (preferred).

Experience and Skills:

:

• Typically10-12years of progressive experience in Quality Assurance Regulatory Affairs or related roles within a regulated industry.

• Demonstrated senior leadership experience managing multicountry or regional QARA organizations.

• Strong working knowledge of EU MDR and European regulatory frameworks.

• Experience supporting audits inspections and health authority interactions at a regional level.

• Proven ability to influence senior stakeholders andoperateeffectively in a matrixed environment.

Preferred:

• Experience in medical devices orthopedics or other highly regulated healthcare industries.

• Experience working withinInternationalor emerging market regulatory operating models.

• Familiarity with CEE market regulatory requirements and business environments.

• Experience leading regulatory or quality transformations across regions.

• Regulatory Affairs Certification (RAC) or equivalent.

• Belgian citizenship with valid passport.

• Strong strategic thinking communication and decisionmaking skills.

Other:

• Language: English;additionalEuropean languages preferred.

• Travel: Moderate regional and occasional international travel.

• Certifications: Regulatory or Quality certifications preferred but not.