7 часов назад
Regulatory Affairs Leader (MedTech)
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Regulatory Affairs Leader (MedTech): Leading regulatory strategies, submissions, and lifecycle activities for interatrial shunting medical devices in EMEA with an accent on EU MDR, CE marking, ISO 13485, and regulatory compliance. Focus on preparing complex technical documentation, engaging Notified Bodies and regulatory authorities, managing audits, and aligning cross-functional teams on regulatory risks and product development requirements.
Location: Caesarea, Haifa District, Israel
Company
Johnson & Johnson MedTech develops innovative, less invasive, and personalized healthcare solutions across cardiovascular care and other medical fields.
What you will do
- Develop and implement regulatory strategies supporting product development, manufacturing, distribution, and lifecycle management.
- Prepare, lead, and maintain EU MDR technical documentation, submissions, CE marking activities, change notifications, renewals, technical reports, and agency certifications.
- Provide regulatory guidance, assess risks and opportunities, and advise management on emerging issues and authority expectations.
- Review product release status, marketing materials, development documentation, FMEAs, test plans, specifications, labeling, and other regulatory outputs.
- Partner with Quality, Clinical, Post-Market Surveillance, R&D, Manufacturing, and Marketing teams to ensure compliance with MDR, ISO 13485, and related requirements.
- Lead compliance activities, vigilance reporting, regulatory projects, employee training, interactions with European Notified Bodies, and internal and external inspections.
Requirements
- Bachelor’s degree or equivalent in Engineering, Science, or a related discipline.
- 7–10 years of professional experience in Regulatory Affairs.
- At least 5 years of experience with MDR, MDD, and CE marking submissions.
- Experience preparing major regulatory submissions, amendments, supplements, and regulatory authority communications, including IDE, PMA, CE Design Dossiers, and Technical Files.
- Knowledge of medical-device Quality Management System requirements, particularly ISO 13485, and experience managing audits with auditors and Competent Authority representatives.
- Ability to lead cross-functional teams, interpret technical and clinical information, solve complex problems, and communicate effectively with stakeholders and regulatory agencies.
Nice to have
- Graduate degree in Engineering, Science, or a related discipline.
- Regulatory Affairs Certification (RAC).
- Experience with MDR Class III risk medical devices.
Culture & Benefits
- Inclusive work environment focused on respecting individual diversity and dignity.
- Opportunity to contribute to cardiovascular solutions for heart recovery, electrophysiology, stroke, heart failure, and atrial fibrillation care.
- Cross-functional collaboration across scientific, clinical, manufacturing, quality, research, and marketing disciplines.
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