O pozici
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Regulatory Affairs Group Job Sub Function: Regulatory Affairs Job Category: Professional All Job Posting Locations: Prague, Czechia, Warsaw, Masovian, Poland Job 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.
Co budeš dělat
- 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.
Koho hledáme
- 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, commun
