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Project Manager Regulatory Affairs - AMD

Company: Abbott Laboratories
Location: Des Plaines
Posted on: January 15, 2022

Job Description:

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 109,000 colleagues serve people in more than 160 countries. 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 109,000 colleagues serve people in more than 160 countries.At Abbott Molecular, we realize the potential of personalized care as the laboratory's most trusted and preferred source for molecular diagnostic solutions. We are a division of Abbott Laboratories, a global, diversified healthcare innovator with a legacy of pioneering work in medical diagnostics. Abbott Molecular (AMD) Our Des Plaines, IL site has an opportunity for the Project Manager Regulatory Affairs - AMDAs an individual contributor, the function of a Regulatory Affairs Project Manager is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. The individual has department/group/site level influence and is generally recognized as an expert resource within the department. The individual may share knowledge and expertise with others in support of team activities. The individual may identify data needed, obtain these data and ensure that they are effectively presented for the registration of products worldwide. WHAT YOU WILL DO: Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Core job responsibilities for this function may include: --- Develop new regulatory policies, processes and SOPs and train key personnel on them. Evaluate regulatory risks of division policies, processes, procedures.Provide regulatory input to product lifecycle planning. Monitor regulatory outcomes of initial product concepts and provide input to senior regulatory management. Assist in the development of multi-country regulatory strategy and update strategy based upon regulatory changes. Assist in regulatory due diligence for potential and new acquisitions.Utilize technical regulatory skills to propose strategies on complex issues.Determine submission and approval requirements. Identify emerging issues. Monitor trade association positions for impact on company products.Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams. Recruit, develop and mentor regulatory professionals.Assess the acceptability of quality, preclinical and clinical documentation for submission filing. Evaluate risk of and regulatory solutions to product and clinical safety issues during clinical phases and recommend solutions. Compile, prepare, review and submit regulatory submission to authorities.Monitor impact of changing regulations on submission strategies and update internal stakeholders. Monitor applications under regulatory review. Communicate application progress to internal stakeholders. Monitor and submit applicable reports and ensure appropriate responses are submitted to regulatory authorities. Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies. Negotiate and interact 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 and execute preapproval compliance activities.Oversee processes involved with maintaining annual licenses, registrations, listings and patent information. Ensure compliance with product post-marketing approval requirements.Review and approve advertising and promotional items to ensure regulatory compliance. Ensure external communications meet regulations. Develop, implement and manage appropriate SOPs and systems to track and manage product-associated events --- Actively contribute to the development and functioning of the crisis/issue management program. Oversee system to ensure that product safety issues and product-associated events are reported to regulatory agencies ---- Report adverse events to regulatory agencies and internal stakeholders. Provide regulatory input for product recalls and recall communications. ACCONTABILITY: Individuals execute and manage technical and scientific regulatory activities.Must function independently as a decision-maker on regulatory issues and must assure that deadlines are met.Effectively communicate, prepare, and negotiate both internally and externally with various regulatory agencies.Properly interpret and apply regulatory requirements.Work is performed without appreciable direction and exercises some latitude in determining technical objectives of assignments.Completed work is reviewed from a relatively long- term perspective for desired results.Individual is recognized as a discipline expert and resource in regulatory affairs. EDUCATION AND EXPERIENCE, YOU'LL BRING: Required:

  • Bachelor's degree (or equivalent), Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering
    • 2-5 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations.
      • 4-5 years' experience in a regulated industry (e.g., medical products, nutritional's) Preferred:
        • Bachelor's degree in medical fields is preferred
        • M.S. in a technical area or M.B.A. is preferred. A Ph.D. in a technical area or law is helpful. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society). WHAT WE OFFER - -At Abbott, you can have a good job that can grow into a great career. We offer: -
          • A fast-paced work environment -where your safety is our priority (Include for Manufacturing roles only) -
          • Production areas that are -clean, well-lit and temperature-controlled -(Include for -Manufacturing roles only) -
          • Training and career development, with onboarding programs for new employees and tuition assistance - -
            • Financial security -through competitive compensation, incentives and retirement plans - -
            • Health care and well-being programs -including medical, dental, vision, wellness and occupational health programs -
            • Paid time off - -
            • 401(k) -retirement savings with a generous company match -
            • The stability of a company -with a record of strong financial performance and history of -being actively involved in local communities - Learn more about our benefits that add real value to your life to help you live fully:--- - - -Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity. -Connect with us at, on LinkedIn at, on Facebook at and on Twitter

Keywords: Abbott Laboratories, Des Plaines , Project Manager Regulatory Affairs - AMD, Executive , Des Plaines, Illinois

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