Senior Regulatory Affairs Specialist, Medical Devices (US/EU) – Hybrid

Becton Dickinson NA; Covington (GA); Híbrido; USD 110 000 - 140 000; Tempo integral

Resumo da oferta

Becton Dickinson NA is seeking a Senior Regulatory Affairs Specialist to lead regulatory submissions (FDA 510(k), EU MDR) and maintain quality systems for U.S. and international markets. The role supports RA management and regulatory strategy across product lifecycles.

The position offers on-site work four days per week in Covington, GA, with remote Fridays, and requires 4+ years of medical device regulatory experience and strong documentation skills.

Qualificações

• Bachelor of Science in a scientific discipline, engineering or regulated field.
• Minimum 4 years of Regulatory Affairs experience in medical devices.
• Experience with product registration, regulatory compliance and quality system activities.

Responsabilidades

• Regulatory support through the product life cycle on project teams, including strategy, change control, timelines and submission reviews.
• Prepare and revise STED/Technical Files for CE marking and interaction with Notified Bodies.
• Support post-market activities including remedial actions and labeling.
• Prepare/assist FDA 510(k) submissions and change assessments.
• Travel up to 15% as needed.

Conhecimentos

Regulatory strategy

FDA 510(k)

EU MDR

Technical writing

Cross-functional teamwork

Regulatory submissions

Project management

Communication skills

Formação académica

BS in Science/Engineering

Ferramentas

RAC certification

Descrição da oferta de emprego

Becton Dickinson NA is seeking a Senior Regulatory Affairs Specialist to lead regulatory submissions (FDA 510(k), EU MDR) and maintain quality systems for U.S. and international markets. The role supports RA management and regulatory strategy across product lifecycles.

The position offers on-site work four days per week in Covington, GA, with remote Fridays, and requires 4+ years of medical device regulatory experience and strong documentation skills.