Regulatory Affairs Specialist II – Vascular Devices

Abbott; Temecula (CA); Vor Ort; USD 61.000 - 123.000; Vollzeit

Zusammenfassung

Abbott is seeking a Regulatory Affairs Specialist II to support EU and US regulatory activities for vascular devices, based on-site in Temecula, CA. You will collaborate with global teams to maintain regulatory compliance across a portfolio of endovascular products.

The role demands strong regulatory knowledge, experience with submissions, and excellent communication. A bachelor’s degree is required, with Master’s preferred; prior device regulatory work is a plus.

Qualifikationen

• Bachelor’s degree or equivalent required.
• 2–3 years in a regulated industry; regulatory area preferred.
• Strong verbal and written communication across levels.
• Experience with medical device regulations is a plus.

Aufgaben

• Evaluate regulatory impact and develop global regulatory strategies for product lifecycle.
• Prepare and support regulatory submissions for Vascular devices.
• Assess changes to determine regulatory impact and submission requirements.
• Develop regulatory assessments supporting design control and change management.
• Review and approve engineering change orders related to regulatory documents.
• Serve as regulatory representative for guidelines review and analysis.
• Support maintenance of regulatory approvals and registrations for marketed products.
• Assist product release with Regulatory Operations to ensure compliant launches.

Kenntnisse

Regulatory knowledge

Regulatory submissions

Communication skills

Team collaboration

Ausbildung

Bachelor’s degree

Master’s degree (preferred)

Tools

EDMS

PLM systems

Regulatory software

Jobbeschreibung

Abbott is seeking a Regulatory Affairs Specialist II to support EU and US regulatory activities for vascular devices, based on-site in Temecula, CA. You will collaborate with global teams to maintain regulatory compliance across a portfolio of endovascular products.

The role demands strong regulatory knowledge, experience with submissions, and excellent communication. A bachelor’s degree is required, with Master’s preferred; prior device regulatory work is a plus.