Regulatory Affairs Specialist II

Abbott • Lake Forest, CA

2d • Onsite

About The Position

This position works out of our Lake Forest, IL location in the Core Lab Diagnostics Division. We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people. The Regulatory Affairs Specialist II is responsible for implementing and maintaining the effectiveness of the quality system. Supports manufacturing/operations day-to-day activities for change control. Provides regulatory directions on team activities. Apply basic regulatory understanding to support product and teams. Prepares U.S. regulatory submissions and/or registration documents for international affiliates and government agencies worldwide. Handles regulatory activities involved in documentation, labeling, field support. Applies regulatory and technical knowledge to a focused area of work assignments. Understands, implements, and maintains the quality policy. Ensures compliance and is able to demonstrate knowledge of site and division level policies and procedures.

Requirements

• Bachelor’s Degree preferably in a technical discipline such as biology, chemistry, microbiology, immunology, medical technology, etc. Or, and equivalent combinations of education and work experience.
• Minimum 5-year experience

Nice To Haves

• Medical Devices experience preferred.
• Desire 1-2 years of regulatory experience preferably in in-vitro diagnostics.
• RAPS Certification preferred.

Responsibilities

• Verifies with supervisory staff and executes regulatory requirements in relation to product development, submissions, product maintenance, and project plans.
• Implements Division Regulatory Strategy in specific product related activities.
• Analyzes the input of cumulative product changes to current product submissions.
• Share knowledge with others in department and on teams.
• Provides solutions to a variety of problems where analysis requires moderate degree of evaluation.
• Prepares and aligns impact goals with department goals.
• Establishes and executes against project goals and implements plans.
• Provides input to establishing group plans and implementation of those plans.
• Follows GMP guidelines and procedures.
• Writes Effectively: Prepares written information in a clear and concise fashion, appropriately designed for varying target audiences.
• Responsible for implementing and maintaining the effectiveness of the quality system.
• For products division-wide: Advises and communicates to project, group, or venture regarding basic regulatory strategies.
• Support projects related to Research Use Only products.
• Signs-off at team level within delegated parameters for change control.
• Release authority for labeling/sales/promotional materials.
• Official correspondence with outside regulatory agencies is guided by supervisory staff.
• Conducts basic negotiations on routine product related issues with government agencies.
• Follows through on submission related activities to secure product approval.
• Directs own daily activities by utilizing team goals and division regulatory priorities.
• Provides support to Regulatory Affairs management when working towards resolution of compliance issues assuring these resolutions comply with site and division level policies and procedures and are aligned with the appropriate quality system.
• Obtains supervisory regulatory review on submission documents prior to submission to government agencies.

Benefits

• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution.
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level