Vascular Regulatory Affairs Lead - On-Site

Abbott Laboratories; Temecula (CA); On-site; USD 78,000 - 156,000; Full time

Benefits offered by this job

Competitive salary

On-site work in Temecula

Job summary

Abbott Laboratories is seeking a Senior Regulatory Affairs Specialist for on-site work in Temecula, CA. You will support regulatory activities across the product lifecycle, including filings for US FDA and EU Notified Bodies, with collaboration across functions to ensure on-market access.

Ideal candidates have a strong track record in regulated industries, excellent communication, and the ability to navigate complex submissions in a fast-paced environment.

Qualifications

• Bachelor's degree in a related field or equivalent experience.
• 3–4 years in a regulated industry (medical devices, etc.).
• 2–3 years in regulatory preferred; other areas considered.
• Strong verbal and written communication with regulatory agencies.
• Excellent organizational and attention to detail.

Responsibilities

• Provide regulatory input to product lifecycle planning.
• Prepare and submit regulatory submissions to authorities.
• Monitor regulatory changes and submission strategies.
• Maintain licenses, registrations, and listings.
• Interact with regulatory authorities during development and review.

Skills

Regulatory knowledge

Documentation management

Communication skills

Attention to detail

Cross-functional collaboration

Education

Bachelor's degree (related field)

Master's degree

Job description

Abbott Laboratories is seeking a Senior Regulatory Affairs Specialist for on-site work in Temecula, CA. You will support regulatory activities across the product lifecycle, including filings for US FDA and EU Notified Bodies, with collaboration across functions to ensure on-market access.

Ideal candidates have a strong track record in regulated industries, excellent communication, and the ability to navigate complex submissions in a fast-paced environment.