3 дня назад
Manager, QARA Israel (MedTech)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Manager, QARA Israel (MedTech): Leading quality assurance and regulatory affairs for DePuy Synthes’ orthopaedics portfolio in the Israeli market with an accent on product registrations, lifecycle management, regulatory compliance, and quality systems. Focus on coordinating submissions, managing regulatory and quality risks, supporting inspections and audits, and maintaining compliant market access.
Location: Kfar Saba, Center District, Israel; hybrid
Company
Johnson & Johnson MedTech develops healthcare and medical technology solutions, with this role supporting DePuy Synthes’ orthopaedics portfolio.
What you will do
- Lead quality assurance and regulatory affairs activities for product registrations, renewals, variations, and lifecycle management in Israel.
- Coordinate regulatory submissions, technical documentation, product maintenance, and responses to health authority inquiries.
- Serve as the primary QARA contact for the Israeli market and monitor regulatory, quality, and enforcement changes.
- Partner with Commercial, Operations, Supply Chain, Legal, regional leadership, and Global QARA teams to support business continuity and product supply.
- Support regulatory inspections, quality audits, compliance assessments, and continuous improvement initiatives.
- Help shape regional policy initiatives related to strategy, compliance, and growth.
Requirements
- Bachelor’s degree in Regulatory Affairs, Life Sciences, Engineering, or a related discipline.
- 6–8 years of progressive Quality Assurance and/or Regulatory Affairs experience in medical devices, healthcare, or another regulated industry.
- Strong knowledge of Israeli regulatory requirements and health authority processes.
- Experience managing product registrations and lifecycle activities and applying regulatory and quality requirements to business decisions.
- Ability to manage multiple priorities in a complex, fast-paced, matrixed environment.
- English required; Hebrew preferred.
Nice to have
- Advanced degree or professional certification in Regulatory Affairs or Quality.
- Multi-country QARA portfolio or multinational matrixed organization experience.
- Experience with regulatory inspections, quality audits, health authority interactions, or process improvement.
- Familiarity with EU MDR and related international regulatory frameworks.
- RAC or equivalent certification and strong stakeholder management skills.
Culture & Benefits
- Inclusive work environment focused on diversity, dignity, and equal opportunity.
- Limited travel, including occasional regional or international travel.
- Employment is expected to transition to DePuy Synthes following the planned separation of the orthopaedics business, subject to legal and regulatory approvals.
- Employee support covering wellness, career, and life needs.
Будьте осторожны: если работодатель просит войти в их систему, используя iCloud/Google, прислать код/пароль, запустить код/ПО, не делайте этого - это мошенники. Обязательно жмите "Пожаловаться" или пишите в поддержку. Подробнее в гайде →