Senior Global Regulatory Affairs Manager - Medical Devices

eTeam; New Jersey; Presencial; USD 80.000 - 100.000; Tempo integral

Resumo da vaga

eTeam is seeking a qualified candidate to manage regulatory documentation and support international registrations for medical devices in New Jersey. The ideal candidate will exhibit competence in US and foreign regulations, possess strong project management skills, and handle proprietary information confidentially.

Applicants should have a bachelor’s degree in science or biomedical engineering, with 4–6 years of relevant experience in regulatory activities. An advanced degree and RAC Certification are desirable, with evidence of foreign regulatory approvals being a plus.

Qualificações

• Bachelor degree from accredited college or university in science or related field.
• 4–6 years of experience in regulatory activities for medical devices.
• Experience with foreign regulatory approval/clearance.

Responsabilidades

• Prepare and file regulatory documentation for medical devices.
• Assist in the preparation of international registrations and amendments.
• Manage proprietary information with confidentiality.

Conhecimentos

Project management

Oral communication

Problem-solving

Decision making

Formação

Bachelor degree in science or biomedical engineering

Advanced degree

RAC Certification

Descrição da vaga

eTeam is seeking a qualified candidate to manage regulatory documentation and support international registrations for medical devices in New Jersey. The ideal candidate will exhibit competence in US and foreign regulations, possess strong project management skills, and handle proprietary information confidentially.

Applicants should have a bachelor’s degree in science or biomedical engineering, with 4–6 years of relevant experience in regulatory activities. An advanced degree and RAC Certification are desirable, with evidence of foreign regulatory approvals being a plus.