Manager, Regulatory Affairs
AbbottAbout the role
JOB DESCRIPTION:
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:
Career development with an international company where you can grow the career you dream of .
Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
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.
A company recognized as a great place to work in dozens of countries around the world 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 a best place to work for diversity, working mothers, female executives, and scientists.
The Opportunity
This position works out of our Lake Forest, IL office with Rapid Diagnostics.
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 Manager, Regulatory Affairs, will work in the Abbott Rapid Diagnostics Division. The main responsibility of this role is to combine knowledge of scientific, regulatory, and business issues to enable products that are developed, manufactured or distributed to meet required regulations. The person hired has an opportunity to execute highly complex and specialized projects as well as interface with regulatory agencies. This position does not have direct reports.
What You’ll Work On
As the Manager, Regulatory Affairs, you will be responsible for assessing cumulative changes within the existing product portfolio, creating robust regulatory strategies, working with cross-functional teams as the regulatory SME, compiling regulatory submissions, and ensuring data is effectively presented for the registration of products worldwide.
What You’ll Work On
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
Represent Regulatory Affairs on cross functional project teams and provide strategic input and technical guidance on regulatory requirements for in vitro diagnostic devices.
Assess cumulative changes proposed or implemented for on-market products.
Develop global regulatory strategies (Various international markets including working with FDA) and update based upon regulatory changes.
Utilize technical regulatory skills to propose strategies on complex issues.
Create project plans and timelines.
Write and edit submission documents.
Administer/meet regulatory requirements to achieve excellent compliance status with no enforcement actions.
Negotiate with regulatory authorities during the development and review process to ensure submission clearance/approval.
Review and approve labeling to ensure compliance.
Provide strategic input and technical guidance on regulatory authority queries.
Perform submission risk assessment and provide guidance for how risk can be mitigated or lowered.
Ensure that data are identified, obtained and effectively presented for the registration of products worldwide.
Provide regulatory support for internal and external audits.
Required Qualifications
Bachelor's degree
5 years of experience in a regulated industry (e.g., medical products, in vitro diagnostics).
5 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. Note: Higher education may compensate for years of expe
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