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Regulatory Affairs Leader
PresencialTiempo completoMedical Devices
Lead EMEA regulatory affairs for a cardiovascular medical device business in Caesarea, Israel. Own regulatory strategy, submissions, compliance activities, and strategic projects across the product lifecycle.
Responsabilidades
- Develop regulatory strategies incorporating scientific, regulatory, and business considerations for product development, manufacturing, distribution, and lifecycle management.
- Prepare, lead, and maintain EU MDR technical documentation, submissions, change notifications, certificate renewals, technical reports, and agency certifications supporting CE marking.
- Provide regulatory guidance on authority expectations, regulatory risk, emerging issues, and business opportunities.
- Review and approve product release status, marketing materials, product documentation, FMEAs, test plans, reports, specifications, labeling, and other regulatory outputs.
- Partner with Quality, Clinical, Post-Market Surveillance, R&D, Manufacturing, and Marketing teams to align regulatory plans with business strategies.
- Develop and improve regulatory policies, processes, standard operating procedures, and quality system practices.
- Coordinate compliance activities, including vigilance reporting, and lead regulatory projects and employee training.
- Manage budgets for product registrations and renewals.
- Lead interactions with European Notified Bodies and support internal and external inspections related to ISO 13485 and MDR.
Requisitos
- Bachelor’s degree or equivalent in Engineering, Science, or a related discipline.
- At least 7 years of Regulatory Affairs experience.
- At least 5 years of MDR, MDD, or CE Mark submission experience.
- Experience preparing major regulatory submissions, amendments, and supplements.
- Experience collaborating with regulatory authorities, auditors, and Competent Authority representatives.
- Knowledge of medical device quality management systems, particularly ISO 13485.
- Ability to interpret regulations, guidelines, policies, technical information, and scientific literature.
- Experience with submissions such as IDE, PMA, CE Design Dossiers, and Technical Files.
- Strong written communication, analytical reasoning, problem-solving, and stakeholder collaboration skills.
Se valora
- Graduate degree in Engineering, Science, or a related discipline.
- Regulatory Affairs Certification (RAC).
- Experience with MDR Class III risk medical devices.