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Associate Director Regulatory Affairs

Associate Director Regulatory Affairs

AbbottSan Diego, CA, US
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Associate Director Regulatory Affairs

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 student debt program, and 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.

This position 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.

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.

Responsibilities include interfacing with regulatory agencies and trade associations and providing executive management with regulatory metrics and information. The individual will ensure data is identified, obtained, and effectively presented for product registration worldwide (US, FDA, CE-IVDR, PMDA, etc.).

Strategic Planning :

  • Identify and approve new regulatory policies, processes, and SOPs.
  • Evaluate regulatory risks of corporate policies.
  • Provide strategic guidance for product development and planning throughout the product lifecycle.
  • Analyze and compare 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 :

  • Approve regulatory filing strategies based on proposed preclinical, clinical, and manufacturing changes.
  • 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 strategic input and technical guidance on regulatory requirements to development teams.
  • Manage preapproval compliance activities.
  • Formulate company procedures to respond to regulatory authority queries.

    • 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.
  • 7+ years' experience in a regulated industry, +7 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.

    • Regulatory Knowledge of (as applicable) :

  • 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
  • Submission / registration types and requirements
  • GxPs (GCPs, GLPs, GMPs)
  • 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.

    • Preferred Qualifications

  • A Ph.D. in a technical area or law is helpful. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society).

    • The base pay for this position is $146,700.00 $293,300.00. In specific locations, the pay range may vary from the range posted.

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    Associate Regulatory • San Diego, CA, US

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