Regulatory Affairs Specialist II, Vascular Devices

Abbott; United States; Presencial; USD 85 000 - 120 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Free HIP PPO medical plan

Generous retirement plan

Tuition reimbursement

FreeU education benefit

Employee development

Resumo da oferta

Abbott is seeking a passionate Regulatory Affairs Specialist II to join the Vascular Division on-site in Temecula, CA. You will support EU and US regulatory activities, ensuring regulatory compliance across a portfolio of endovascular medical devices.

Ideal candidate has strong analytical and project management skills, knowledge of medical device regulations, and the ability to translate complex requirements into product lifecycle activities. Prior experience with submissions is preferred.

Qualificações

• Bachelor's degree or equivalent in a related field.
• 2-3 years' experience in a regulated industry. Regulatory area preferred.
• Ability to work in a fast-paced, matrixed environment.
• Strong verbal and written communications at multiple levels.

Responsabilidades

• Evaluate regulatory impact and develop global regulatory strategies.
• Prepare and support regulatory submissions for vascular devices.
• Review engineering change orders and related documentation.
• Maintain regulatory approvals and registrations for products.
• Comply with FDA and international regulations and company policies.

Conhecimentos

Regulatory knowledge

Project management

Team collaboration

Communication skills

Formação académica

Bachelor's degree or equivalent

Ferramentas

Document control systems

Descrição da oferta de emprego

Abbott is seeking a passionate Regulatory Affairs Specialist II to join the Vascular Division on-site in Temecula, CA. You will support EU and US regulatory activities, ensuring regulatory compliance across a portfolio of endovascular medical devices.

Ideal candidate has strong analytical and project management skills, knowledge of medical device regulations, and the ability to translate complex requirements into product lifecycle activities. Prior experience with submissions is preferred.