Manager QARA CEE, Baltics, Balkans
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Job Function:
Regulatory Affairs GroupJob Sub Function:
Regulatory AffairsJob Category:
ProfessionalAll Job Posting Locations:
Prague, Czechia, Warsaw, Masovian, PolandJob Description:
DePuy Synthes is recruiting for a(n) Manager, QARA CEE, Baltics, Balkans, located in Warsaw, Poland or Prague, Czechia
Job Overview
The Manager, QARA CEE, Baltics, Balkans, provides operational leadership for quality assurance and regulatory affairs across Central & Eastern Europe, the Baltics, and the Balkans. This role is responsible for ensuring regulatory compliance, effective quality management system execution, and sustained market access for DePuy Synthes’ Orthopedics portfolio across multiple, diverse European markets.
The role 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 country‑specific 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 cross‑functional 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 impacts to products, portfolios, and operations.
Support and participate in regulatory inspections, quality audits, and compliance assessments as required.
Contribute to continuous improvement initiatives to enhance QARA efficiency, compliance consistency, and inspection readiness across the region.
Ensuring proactive engagement and shaping of regional policy initiatives that are critical to business strategy, continuity, and growth.
Qualifications
Education
Required: Bachelor’s degree in Regulatory Affairs, Life Sciences, Engineering, or a related discipline.
Preferred: Advanced degree or professional certification in Regulatory Affairs, Quality, or a related field.
Experience and Skills
Required:
6–8 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, fast‑paced, and matrixed environment.
Preferred:
Experience supporting or multi‑country 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, post‑market 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 required; additional regional languages preferred.
Travel: Moderate regional travel across CEE, Baltics, and Balkans.
Certifications: RAC or equivalent preferred but not required.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.
Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
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Required Skills:
Preferred Skills:
Analytical Reasoning, Business Writing, Coaching, Compliance Risk, Fact-Based Decision Making, Industry Analysis, Legal Support, Process Improvements, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Strategic Thinking, Technical CredibilityYou'll be redirected to
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