Regulatory Affairs Specialist II

About the role

The Regulatory Affairs Specialist II position is located in the Core Lab Diagnostics Division of Abbott, a global healthcare leader. This role supports smarter medical and economic decision-making to help transform how people manage their health.

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.
• Provides regulatory directions on team activities.
• Sets up and executes against project goals and implements plans.
• Shares knowledge with others in department and on teams.
• Prepares written information in a clear and concise fashion, appropriately designed for varying target audiences.
• Follows GMP guidelines and procedures.
• Writes effectively.
• 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.
• Ensures compliance and demonstrates 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 equivalent combination of education and work experience.
• Minimum 5 years of experience.
• Prior medical devices experience preferred.
• Desired 1-2 years of regulatory experience preferably in in-vitro diagnostics.
• RAPS Certification preferred.

Qualifications

• Basic understanding of laws and regulations.
• Ability to analyze cumulative product changes to current product submissions.
• Knowledge of GMP guidelines and procedures.
• Ability to follow regulatory and technical knowledge to a focused area of work assignments.
• Understanding, implementation, and maintenance of the quality policy.

Skills

• Strong communication skills.
• Excellent problem-solving abilities.
• Attention to detail.
• Ability to work independently and as part of a team.

Benefits

At Abbott, employees can enjoy a comprehensive benefits package including:

• Health Investment Plan (HIP) PPO medical plan.
• Adequate retirement savings plan with a high employer contribution.
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit.
• A company recognized as one of the best places to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

Pay

$68,000.00 – $136,000.00