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**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, QARA Israel, located in Kfar Saba, Center District, Israel.
The Manager, QARA 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.
This 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.
Travel: Limited; occasional regional or international travel.
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.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.
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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 Credibility