Regulatory Affairs Specialist II — Medical Devices (Orthopaedics)

Brighter Signals; Florida; Presencial; USD 76 000 - 122 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Vacation time

Sick time

Holiday pay

Parental Leave

Resumo da oferta

Johnson & Johnson is seeking a Regulatory Affairs Specialist II to support DePuy Synthes Joint Reconstruction and VELYS Digital Surgery lines. The role requires regulatory judgment, cross-functional collaboration, and project oversight to ensure compliance with FDA, EU MDR/MDR and ISO standards.

The position involves preparing regulatory submissions, reviewing product changes, labeling, and providing guidance to project teams. An annual base pay range is disclosed and benefits are outlined.

Qualificações

• BA/BS degree with minimum 2 years Regulatory Affairs experience in medical devices.
• Excellent written and oral communications skills.
• Ability to handle multiple tasks and be detail oriented.
• Knowledge of medical devices with preference for orthopaedics, capital equipment, robotics, and software.
• Familiarity with electronic submission preparation.

Responsabilidades

• Prepare regulatory documentation for DePuy devices (IDE, 510(k), PMA, Technical File, Design Dossier).
• Assist with EU CE marking activities and regional registrations.
• Review engineering changes and assess regulatory impact.
• Determine regulatory impact of manufacturing changes and submission requirements.
• Review labeling and product support information for compliance with regulatory approvals.

Conhecimentos

Regulatory Affairs

Regulatory submissions

Communication skills

Formação académica

BA/BS degree in related field

Descrição da oferta de emprego

Johnson & Johnson is seeking a Regulatory Affairs Specialist II to support DePuy Synthes Joint Reconstruction and VELYS Digital Surgery lines. The role requires regulatory judgment, cross-functional collaboration, and project oversight to ensure compliance with FDA, EU MDR/MDR and ISO standards.

The position involves preparing regulatory submissions, reviewing product changes, labeling, and providing guidance to project teams. An annual base pay range is disclosed and benefits are outlined.