Regulatory Affairs Specialist, Medical Devices (US/EU)

Becton Dickinson; San Diego (CA); Presencial; USD 120.000 - 170.000; Jornada completa

Descripción de la vacante

BD is seeking an experienced Regulatory Affairs professional to prepare and execute submissions for US, Europe, and international markets. You will lead regulatory processes across verification, risk management, usability, reprocessing, and software development to ensure compliance and support product commercialization.

The role requires independent analysis of complex regulatory issues, data evaluation, and development of regulatory strategies aligned with lifecycle management and business

Formación

• Bachelor's degree in Regulatory Science, Biomedical, Pharmaceutical, or related field.
• Minimum of 5 years of Regulatory Affairs experience in the medical device industry, preferably with FDA Class II and/or III devices.
• Experience preparing regulatory submissions (PMA, 510(k), IDE) to FDA and other agencies.

Responsabilidades

• Coordinate and prepare FDA Premarket 510(k) submissions and liaise with FDA.
• Assess need for 510(k) for device changes; prepare non-filing justifications when not required.
• Prepare technical files/dossiers for International Registrations with cross-functional input.
• Review labeling, promotional, and advertising materials for regulatory compliance.
• Represent Regulatory Affairs in product lifecycle development teams and design reviews.

Conocimientos

Regulatory affairs

FDA submissions

510(k) PMA

Regulatory strategy

Cross-functional collaboration

Risk management

V&V Usability

Educación

Bachelor's degree in Regulatory Science or related field

Descripción del empleo

BD is seeking an experienced Regulatory Affairs professional to prepare and execute submissions for US, Europe, and international markets. You will lead regulatory processes across verification, risk management, usability, reprocessing, and software development to ensure compliance and support product commercialization.

The role requires independent analysis of complex regulatory issues, data evaluation, and development of regulatory strategies aligned with lifecycle management and business