Manager, QARA Israel

DePuy Synthes is recruiting for a ManagerQARA Israel located in Kfar Saba Center District Israel.

The ManagerQARA Israelprovides 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.

Thisrole 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 crossfunctional teams including Commercial Operations Supply Chain Legal and Global QARA to support businessobjectivesand supply continuity.

• Monitor regulatory quality and enforcement changes in Israel and assess potential impacts to products 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.

• 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 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 fastpaced and matrixed environment.

Preferred:

• Experience supporting 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 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 crossfunctional collaboration skills.

Other

• Language: English; Hebrew preferred.

• Travel: Limited; occasional regional or international travel.

• Certifications: RAC or equivalent preferred but not.

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 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 internal employees contact AskGS to be directed to your accommodation resource.

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