Senior Specialist Regulatory Affairs

Abbott•Lake Forest, IL

5d•$113,300 - $226,700•Onsite

About The Position

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries. JOB DESCRIPTION: Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your 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. 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. A company recognized as a great place 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. The Opportunity This position, Sr. Specialist, Regulatory Affairs, works out of our San Diego, CA location in the Infectious Diseases Division. This role is part of the RA New Product Introduction (NPI) team, reporting to the Director of Global NPI and U.S. Regulatory Affairs. 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. What You’ll Work On We are seeking a highly knowledgeable individual to combine expertise in scientific, regulatory, and business issues to ensure our products meet required legislation. This role involves significant departmental influence and recognition as an expert resource both within Abbott and externally. The individual will ensure data is identified, obtained, and effectively presented for product registration worldwide Strategic Planning: Identify new regulatory policies, processes, and SOPs in addition to evaluating regulatory risks of current corporate policies. CLIA Waiver, Lateral Flow, International experience are important in this role, the ideal candidate will have experience in all of these areas. Provide guidance for product development and planning throughout the product lifecycle. Analyze regulatory outcomes with initial product concepts and recommend future strategies and actions. Develop and update global regulatory strategies based on regulatory changes. Conduct regulatory due diligence for potential and new acquisitions and advise management. Utilize technical regulatory skills to propose strategies on complex issues. Monitor emerging issues and identify solutions. Monitor trade association positions for impact on company products. Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with regulatory and related teams. Recruit, develop, and mentor regulatory professionals. Premarket: Monitor the impact of changing regulations on submission strategies and update internal stakeholders. Communicate application progress to internal stakeholders. Monitor and submit applicable reports and responses to regulatory authorities. Negotiate with regulatory authorities during the development and review process to ensure submission approval. Provide input and technical guidance on regulatory requirements to development teams. Manage preapproval compliance activities.

Requirements

Bachelor's degree, preferably in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred.
M.S. in a technical area or M.B.A. is preferred.
6+ years' experience in a regulated industry, +6 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 experience.
Background in IVD instruments and software required.
Experience with meeting global (i.e., US FDA, IVDR, PMDA) cybersecurity, EMC, and software requirements.
Regulatory history, guidelines, policies, standards, practices, requirements and precedents.
Regulatory agency structure, processes and key personnel
Principles and requirements of applicable product laws
Knowledge of Principles and Requirements of promotion, advertising and labeling international treaties and regional, national, local and territorial trade requirements.
Agreements and considerations: Domestic and international regulatory guidelines, policies and regulations
Ethical guidelines of the regulatory profession, clinical research and regulatory process.

Nice To Haves

A Ph.D. in a technical area or law is helpful.
Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
CLIA WAIVER, and Lateral Flow experience of at least a few years is ideal.

Responsibilities

Ensure data is identified, obtained, and effectively presented for product registration worldwide
Identify new regulatory policies, processes, and SOPs in addition to evaluating regulatory risks of current corporate policies.
Provide guidance for product development and planning throughout the product lifecycle.
Analyze regulatory outcomes with initial product concepts and recommend future strategies and actions.
Develop and update global regulatory strategies based on regulatory changes.
Conduct regulatory due diligence for potential and new acquisitions and advise management.
Utilize technical regulatory skills to propose strategies on complex issues.
Monitor emerging issues and identify solutions.
Monitor trade association positions for impact on company products.
Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with regulatory and related teams.
Recruit, develop, and mentor regulatory professionals.
Monitor the impact of changing regulations on submission strategies and update internal stakeholders.
Communicate application progress to internal stakeholders.
Monitor and submit applicable reports and responses to regulatory authorities.
Negotiate with regulatory authorities during the development and review process to ensure submission approval.
Provide input and technical guidance on regulatory requirements to development teams.
Manage preapproval compliance activities.

Benefits

Career development with an international company where you can grow the career you dream of.
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.
A company recognized as a great place 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.

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