Manager, QARA Israel
Pharma
Job description
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: Kfar Saba, Center District, Israel Job Description: DePuy Synthes is recruiting for a Manager, QA RA Israel , located in Kfar Saba, Center District, Israel. The Manager, QA RA Israel provides operational leadership for quality assurance and regulatory affairs for the Israel market . This role is accountable for ensuring regulatory compliance, effective quality management system execution, and sustained market access for DePuy Synthes’ Orthopedics portfolio in a highly regulated environment. T h is role plays a critical part in safeguarding patient safety, managing quality and regulatory risk, and enabling compliant business continuity and growth. The Manager partners closely with local market teams, regional leadership, and Global QARA stakeholders to support product lifecycle activities and operational excellence. Key Responsibilities Lead and manage Quality Assurance and Regulatory Affairs activities to support product registrations, renewals, variations, and full lifecycle management for the Israel market. Ensure compliance with Israeli regulatory requirements, internal policies, applicable international standards, and DePuy Synthes quality management system expectations. Serve as the primary QARA point of contact for the Israel local market. Coordinate regulatory submissions, technical documentation, and responses to health authority inquiries, including ongoing product maintenance activities. Partner with cross‑functional teams including Commercial, Operations, Supply Chain, Legal, and Global QARA to support business objectives and supply continuity. Monitor regulatory, quality, and enforcement changes in Israel 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. 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 Israeli regulatory requirements and health authority processes. Experience managing product registrations and lifecycle activities. Ability to interpret and apply regulatory and quality requirements to support business and product decisions. Ability to manage multiple priorities in a complex, fast‑paced, and matrixed environment. Preferred: Experience supporting 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 and related international regulatory frameworks. 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 cross‑functional collaboration skills. Other Language: English required ; Hebrew preferred.</span
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