Senior Regulatory Affairs Lead — Diabetes Care

Thornton Tomasetti; Alameda (CA); On-site; USD 100,000 - 200,000; Full time

Benefits offered by this job

Career development opportunities

Free medical coverage under Health Investment Plan

Retirement savings plan with employer contributions

Tuition reimbursement and education benefits

Job summary

Abbott Laboratories is seeking a Principal Regulatory Affairs Specialist for its Diabetes Care Division in Alameda, California. This role involves developing regulatory strategies for innovative diabetes management products and ensuring compliance with industry standards.

The ideal candidate will have a Bachelor’s degree in a scientific field, substantial experience in regulatory submissions, and strong leadership skills. Join us to help revolutionize health management for people with diabetes.

Qualifications

• Previous experience working with Class II or Class III medical devices required.
• Familiarity with FDA regulations and ISO standards.
• Strong organizational and follow-up skills.

Responsibilities

• Develop regulatory strategies for new product introductions.
• Create project plans and lead functional groups.
• Monitor and ensure compliance with regulations.

Skills

Regulatory submissions experience

Project management

Problem-solving

Strong communication skills

Ability to work in a matrixed environment

Education

Bachelor’s Degree in Scientific discipline

Tools

Microsoft Office Suite

Job description

Abbott Laboratories is seeking a Principal Regulatory Affairs Specialist for its Diabetes Care Division in Alameda, California. This role involves developing regulatory strategies for innovative diabetes management products and ensuring compliance with industry standards.

The ideal candidate will have a Bachelor’s degree in a scientific field, substantial experience in regulatory submissions, and strong leadership skills. Join us to help revolutionize health management for people with diabetes.