Regulatory Affairs Specialist III – Diabetes Care (on-site)

Abbott • Buffalo Grove, IL

11d • $68,000 - $136,000 • Onsite

About The Position

We are recruiting for a Regulatory Affairs Specialist III to join our team on-site in Buffalo Grove, IL. We’re focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology. Our FreeStyle Libre continuous glucose monitors have revolutionized the way roughly 7 million people worldwide manage their diabetes.
This new team member will support manufacturing/operations day-to-day activities for change control and provide regulatory direction on team activities. The individual will apply regulatory understanding to support of product and teams as well as prepare US regulatory submissions and/or registration documents. Additionally, will handle regulatory activities involved in documentation, labeling, field support and apply regulatory and technical knowledge to a focused area of work assignments. This Specialist understands, implements, and maintains the quality policy and ensures compliance to and is able to demonstrate knowledge of site and division level policies and procedures.

Requirements

• Bachelor’s Degree or an equivalent combination of education and experience
• 5 years’ work experience

Nice To Haves

• Bachelor’s degree in a technical discipline such as biology, chemistry, microbiology, immunology, medical technology, engineering, etc.
• 5+ years’ experience in Medical Device industry
• 1-2 years of regulatory experience.
• Effectively communicate, prepare, and negotiate both internally and externally with various regulatory agencies. Communicate effectively verbally and in writing.
• Able to follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues.
• Think analytically with good problem-solving skills.
• 510(k), PMA, or other international regulatory submission experience.
• RAPS Certification.

Responsibilities

• Verifies with supervisory staff and executes regulatory requirements in relation to product development, submissions, product maintenance and project plans.
• Provide technical leadership and strategic input on complex issues and to business units.
• Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams.
• Develop global regulatory strategies for product development and planning throughout the product lifecycle.
• Analyze and compare regulatory outcomes with initial product concepts and recommend future strategies and actions.
• Implements Division Regulatory Strategy in specific product related activities.
• Basic understanding of medical device regulations.
• Obtains supervisory input for interpretation leading to the solution of issues, and to product development and support.
• Analyzes the input of cumulative product changes to current product submissions.
• Lead functional groups in the development of relevant data to complete a regulatory submission.
• Follows through on submission related activities to secure product approval.
• Shares knowledge with others in department and on teams.
• 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.
• Administer/meet regulatory requirements to achieve excellent compliance status with no enforcement actions
• For products division-wide: Advises and communicates to project, group, or venture regarding basic regulatory strategies.
• Signs-off at team level within delegated parameters for change control.
• 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 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