1+ months

SH Regulatory Affairs Project Leader; Regulatory Operations

St Paul, MN 55102
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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 103,000 colleagues serve people in more than 160 countries.

Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease.  We aim to lead the markets we serve by requiring the solutions we offer customers provide an improved benefit/risk profile as compared to existing standards of care; a performance threshold that by definition, guides and ensures the productive output of our engineering, business development, and clinical research efforts result in outcomes that advance the standard of care.

SH Regulatory Affairs Project Leader; Regulatory Operations


The Structural Heart Regulatory Affairs Operations Group is seeking a Project Leader for the Regulatory group to aide in coordinating and managing various Structural Heart Quality System activities. The role is responsible for an array of quality initiatives: from helping to develop processes and procedures, to leading various SH group quality improvement projects (including both QS to CAPA), to assisting in training initiatives, and aiding in evaluating audit findings; working cross-functionally to determine the scope, risk, business impact and resolution.  Success in this role requires skills in project management, critical thinking, problem solving, and interpersonal skills to lead cross functional teams to address compliance concerns.

General – Responsible for preparation, coordination, and deliverables associated with Regulatory Affairs’ role within the Structural Heart Quality System to include representing Regulatory Affairs in audits and establishing/refining processes to facilitate compliance in regulatory affairs activities.  Proactively leads cross-functional compliance activities across the portfolio to identify and mitigate potential risks.  Works with Quality System owners to understand process data, identify potential risks, and collaboratively develop, maintain and implement risk mitigation plans.  Seeks process solutions for compliance to regulatory intelligence inputs to ensure international regulatory requirements are assessed and compliance integrated into programs. 

Quality System Compliance – Creates, develops, and maintains adherence to the various Structural Heart Quality Policies as well as site, Division, and Corporate Quality system procedures. Stays abreast of applicable regulations and standards through training and self-driven continuous learning. Maintains awareness of business and industry compliance trends. Leads various Quality Subsystem projects involving processes such as CAPA. Will support as CAPA approver.

Risk Management - Applies basic Risk Management principles to evaluate potential compliance risks.  Develops an awareness of Division Risk Management policies and procedures and works cooperatively with stakeholders to facilitate smart processes to support nimble business compliance.


Required Experience / Skills / Education:

  • Education & Experience: At least 3 years work experience in Quality / Quality Management or related field experience; Less experience may be appropriate with advanced degree.
  • Skills: Receives general direction and exercises considerable discretion to own work detail.  Identifies and elevates constraints and risks and recommends possible solutions. Ensures compliant and user-friendly documentation; carrying out tasks related to area of responsibility with management oversight. Decisions have short- or long-term impact. Demonstrated ability to identify and ask relevant questions. Customer-service oriented self-starter with excellent analytical, critical thinking, and creative problem-solving skills. Strong desire and ability to learn, adapt, and apply new technologies. Ability to work in a flexible and professional manner. Adept at translating business requirements into compliant solutions. Excellent oral and written communication skills including the ability to communicate effectively with both technical and non-technical stakeholders.

    Additional Responsibilities:

    • Collaborate with local Regulatory Affairs and worldwide affiliates to understand and improve the regulatory affairs processes and requirements.
    • Provide regulatory input for product recalls and recall communications
    • Function as a team lead when Manager is not available, prioritizing work and facilitating issue resolution or escalation.


      • Individual works under minimal supervision and will independently determine and develop approach to solutions.
      • Participates in conflict resolution at the senior individual contributor level.

        Influence/ Leadership:

        • Establishes and cultivates an extensive network of support to facilitate completion of assignments.
        • Participates in the development of less experienced staff by setting an example, providing guidance, and offering counsel.
        • Leads departmental project team.
        • Determines goals and objectives for projects.
        • Influences middle management on technical or business solutions.

          Planning/ Organization:

          • Plans and organizes non-routine tasks.
          • Initiates or maintains work schedule.
          • Establishes priorities of work assignments.

            Decision Making Impact:

            • Exercises judgment in selecting innovative, practical methods to achieve problem resolution.
            • Failure to obtain results or erroneous decisions or recommendations would typically result in serious delays and considerable expenditure of resources.

              Regulatory Knowledge of (as applicable):

              • Strong understanding of business unit function and cross group dependencies/ relationships.
              • Work with cross-functional teams; work with people from various disciplines and cultures.
              • Application of root cause analysis and critical, analytical thinking skills.
              • Create project plans and timelines.
              • Will perform job in a quality system environment; failure to adequate perform tasks can result in noncompliance with governmental regulations.
              • Exercises judgement within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
              • Knowledge of principles and requirements of applicable product laws
              • Knowledge of domestic and international regulatory guidelines, policies and regulations

                WHAT WE OFFER  

                At Abbott, you can have a good job that can grow into a great career. We offer: 

                ·       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 ","industry":"Healthcare","title":"SH Regulatory Affairs Project Leader; Regulatory OperationsDivision: SH Structural Heart
                Travel: Yes, 10 % of the Time
                Medical Surveillance: No
                Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Posted: 2020-08-07 Expires: 2020-11-21

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SH Regulatory Affairs Project Leader; Regulatory Operations

St Paul, MN 55102

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