Manager QARA CEE, Baltics, Balkans

DePuy Synthes is recruiting for a(n) ManagerQARA CEE Baltics Balkanslocatedin WarsawPolandorPragueCzechia

Job Overview

The ManagerQARA CEE Baltics Balkansprovides operational leadership for quality assurance and regulatory affairs across Central & Eastern Europe the Baltics and the Balkans.This roleis responsible forensuring regulatory compliance effective quality management system execution and sustained market access for DePuy Synthes Orthopedics portfolio across multiple diverse European markets.

Therole plays a critical part in managing quality and regulatory risk supporting product lifecycle activities and enabling compliant business continuity and growth in a highly regulated environment. The Manager partners closely with local market teams and global QARA stakeholders to ensure patient safety and compliance excellence.

Key Responsibilities

• Lead and manage Quality Assurance and Regulatory Affairs activities to support product registrations renewals variations and lifecycle management across CEE Baltic and Balkan markets.

• Ensure compliance with countryspecific regulatory requirements EU MDR obligations internal policies and DePuy Synthes quality management system standards.

• Serve as the primary QARA point of contact for assigned CEE Baltics and Balkans markets.

• Coordinate regulatory submissions technical documentation renewals and responses to health authority inquiries.

• Partner with crossfunctional teams including Quality Supply Chain Commercial Legal and Global QARA to support product availability launches and supply continuity.

• Monitor regulatory quality and enforcement changes across assigned markets and assess potential impactstoproducts portfolios and operations.

• Support andparticipatein regulatory inspections quality audits and compliance assessments as.

• Contribute to continuous improvement initiatives to enhance QARA efficiency compliance consistency andinspectionreadiness across the region.

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

Qualifications

Education

• Required: Bachelors degree in Regulatory Affairs Life Sciences Engineering ora relateddiscipline.

• Preferred: Advanced degree or professional certification in Regulatory Affairs Quality ora relatedfield.

Experience and Skills

Required:

• 68 years of progressive experience in Quality Assurance and/or Regulatory Affairs within the medical device healthcare or other regulated industries.

• Strong working knowledge of regulatory requirements across CEE Baltic and Balkan markets including EU MDR.

• Experience managing product registrations and lifecycle activities across multiple countries.

• Ability to interpret regulatory and quality requirements and apply them to business and product decisions.

• Ability to manage multiple priorities in a complex fastpaced and matrixed environment.

Preferred:

• Experience supporting or multicountry QARA portfolios.

• Experience working in a multinational or matrixed organization.

• Exposure to regulatory inspections quality audits or health authority interactions.

• Familiarity with EU MDR implementation postmarket surveillance and vigilance requirements.

• Demonstrated experience contributing to regulatory or quality process improvement initiatives.

• Regulatory Affairs or Quality certification (e.g. RAC or equivalent).

• Strong stakeholder management communication and collaboration skills.

Other

• Language: English;additionalregional languages preferred.

• Travel: Moderate regional travel acrossCEE Baltics and Balkans.

• Certifications: RAC or equivalent preferred but not.