JOB DESCRIPTION:Regulatory Affairs Specialist II
The Opportunity
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.
What You’ll Work On
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.
Basic understanding of laws and 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.
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.
Required Qualifications
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
Preferred Qualifications
Medical Devices experience preferred.
Desire 1-2 years of regulatory experience preferably in in-vitro diagnostics.
RAPS Certification preferred.
Apply Now
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: https://abbottbenefits.com/
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life.
The base pay for this position is
$68,000.00 – $136,000.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:Regulatory Operations
DIVISION:CRLB Core Lab
LOCATION:United States > Lake Forest : CP01
ADDITIONAL LOCATIONS:
WORK SHIFT:Standard
TRAVEL:Yes, 5 % of the Time
MEDICAL SURVEILLANCE:Not Applicable
SIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)
