Regulatory Ops Specialist - Vascular Devices & Audits

Thornton Tomasetti; Temecula (CA); Sur place; USD 1 300 - 123 000; Plein temps

Avantages offerts par ce poste

Health coverage

Tuition reimbursement

Retirement plan with high employer 1d

Education benefits

Résumé du poste

Abbott Vascular is seeking a Regulatory Affairs Operations Specialist to join our Temecula, CA team on-site. You will partner with internal and external stakeholders to keep the quality system current and effective amid evolving regulatory requirements.

This role supports Audit Readiness, CAPA, Change Management, and KPI reporting, ensuring compliance with FDA and international regulations, 21 CFR 820, ISO 13485, and EU MDR where applicable.

Qualifications

• Bachelor’s degree in scientific discipline, engineering, or medical fields.
• 2-3 years’ experience in a regulated industry (medical products, nutritionals, pharmaceuticals).
• Strong verbal and written communications with ability to communicate at multiple levels.

Responsabilités

• Maintain quality system alignment with evolving regulatory landscape.
• Support Audit Readiness Program and KPI management.
• Assist in Change Management, CAPAs, and regulatory compliance activities.

Connaissances

Verbal and written communication

Team orientation

Ability to work in fast-paced matrixed

Formation

Bachelor’s degree in science/engineering/medical fields

Advanced degree (preferred)

Description du poste

Abbott Vascular is seeking a Regulatory Affairs Operations Specialist to join our Temecula, CA team on-site. You will partner with internal and external stakeholders to keep the quality system current and effective amid evolving regulatory requirements.

This role supports Audit Readiness, CAPA, Change Management, and KPI reporting, ensuring compliance with FDA and international regulations, 21 CFR 820, ISO 13485, and EU MDR where applicable.