Senior Regulatory Affairs Lead, Medical Devices – Vascular

Abbott Laboratories; Temecula (CA); On-site; USD 87,000 - 173,000; Full time

Job summary

Abbott Laboratories seeks a Principal Regulatory Affairs Specialist to lead regulatory activities for vascular devices in the US, EU, and global markets. On-site in Santa Clara or Temecula, you will guide cross-functional teams and manage complex regulatory submissions across lifecycle stages.

The role requires strong knowledge of 21 CFR 820, ISO 13485, and EU MDR, with a proven track record in medical device regulatory leadership.

Qualifications

• Bachelor's degree in science or equivalent.
• Experience submitting regulatory documents for medical devices.
• Familiarity with US FDA and EU MDR processes.

Responsibilities

• Develop and execute global regulatory strategies for endovascular devices.
• Prepare regulatory submissions and associated documentation.
• Lead regulatory assessments for design changes and manufacturing transfers.
• Collaborate across Regulatory, Quality, Clinical, and R&D teams.

Skills

Regulatory strategy

FDA submissions

EU MDR compliance

Medical devices

Cross-functional leadership

Education

Bachelor's degree in science or related

Tools

EDMS

eQMS

PLM

Job description

Abbott Laboratories seeks a Principal Regulatory Affairs Specialist to lead regulatory activities for vascular devices in the US, EU, and global markets. On-site in Santa Clara or Temecula, you will guide cross-functional teams and manage complex regulatory submissions across lifecycle stages.

The role requires strong knowledge of 21 CFR 820, ISO 13485, and EU MDR, with a proven track record in medical device regulatory leadership.