Current jobs related to Lead Regulatory Affairs Consultant - Irving, Texas - Abbott

  • Senior Regulatory Affairs Specialist

    4 weeks ago

    Irving, Texas, United States Abbott Laboratories Full time

    Job SummaryAbbott Laboratories is seeking a highly skilled Senior Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements and guidelines for our medical devices and pharmaceuticals.About the RoleThis is a challenging and rewarding role that requires a...

  • Food Safety Regulatory Affairs Specialist

    10 hours ago

    Irving, Texas, United States LSG Sky Chefs Full time

    Job Title: Food Safety Regulatory Affairs ManagerJob Summary:LSG Sky Chefs is seeking a Food Safety Regulatory Affairs Manager to develop and maintain comprehensive food safety programs based on FSSC 22000, FDA FSMA, and customer standards.Main Responsibilities:• Design and write comprehensive food safety programs that align with FSSC 22000 and FDA FSMA...

  • Business Execution Consultant

    4 weeks ago

    Irving, Texas, United States WELLS FARGO BANK Full time

    About this RoleWe are seeking a highly skilled Business Execution Consultant to join our Corporate Risk Regulatory Execution team in the Health Check Team. As a key member of our team, you will work closely with issue owners and accountable executives to ensure action plans are designed for success, review ongoing execution of selected issues, and drive...

  • Regulatory Compliance Specialist

    1 month ago

    Irving, Texas, United States Celanese Corporation Full time

    Job Title: North American Regulatory ExpertCelanese Corporation is seeking a highly motivated and detail-oriented Regulatory Professional to join our growing Product Stewardship team.Responsibilities:Ensure marketability of Celanese products under regulatory aspects, including review and performance of processes to ensure timely inventory reporting, new...

  • Regulatory Project Manager

    4 weeks ago

    Irving, Texas, United States Pinnacle Group, Inc. Full time

    Regulatory Project ManagerPinnacle Group, Inc. is seeking a highly skilled Regulatory Project Manager to join our team in Irving, TX.This is a 12-month contract position with the possibility of extension or hire.The successful candidate will have a strong background in strategy development and execution, with experience in regulatory projects.Key...

  • Senior Risk Management Consultant

    5 days ago

    Irving, Texas, United States Collabera Full time

    Job Title: Senior Risk Management ConsultantJob Summary:Collabera is seeking a highly skilled Senior Risk Management Consultant to join our team. As a Senior Risk Management Consultant, you will be responsible for providing project governance, oversight, and monitoring activities by the WCR initiative and processes specified by the Transformation Program...

  • Physician Leadership Consultant

    1 month ago

    Irving, Texas, United States Vizient Full time

    Lead Clinical Operations at VizientWe're seeking a seasoned physician leader to join our team at Vizient. As a key member of our operations team, you'll provide strategic guidance and consulting services to our clients, leveraging your expertise in internal medicine and hospitalist care.Responsibilities:Leverage your expertise to drive business growth and...

  • Clinical Operations and Regulatory Attorney

    1 week ago

    Irving, Texas, United States CHRISTUS Health Full time

    Job SummaryThe Clinical Operations and Regulatory Attorney will work independently at a law firm partner level in collaboration with other applicable internal and external counsel, as well as leaders within the multi-entity, nonprofit healthcare system known as CHRISTUS Health.Key ResponsibilitiesLead the work of the Clinical Operations and Regulatory team...

  • Business Execution Senior Manager

    4 weeks ago

    Irving, Texas, United States Wells Fargo Full time

    About the RoleWe are seeking a highly skilled Business Execution Senior Manager to join our Corporate Risk Regulatory Execution team in the Health Check Team. As a key member of our team, you will play a critical role in ensuring the successful execution of regulatory initiatives and driving business excellence across the organization.Key...

  • Lead Data Engineer

    2 weeks ago

    Irving, Texas, United States Wells Fargo Full time

    About this role:Wells Fargo is seeking a skilled Data Engineer to join our Auto Data Technology Team. As a key member of this team, you will play a critical role in the modernization of our auto data platform and be responsible for developing technology solutions to support complex business processes.This position will require you to lead complex...

  • Senior Legal Counsel

    1 week ago

    Irving, Texas, United States CVS Health Full time

    At CVS Health, we're committed to delivering enhanced human-centric healthcare for a rapidly changing world. As a key member of our team, you'll play a vital role in shaping our culture and driving innovation.Position SummaryWe're seeking a seasoned Senior Legal Counsel to provide strategic legal advice to internal business partners on healthcare programs...

  • Digital Product Manager Lead

    2 weeks ago

    Irving, Texas, United States Wells Fargo Full time

    About this role:We are seeking a highly skilled Lead Digital Product Manager to join our Commercial Banking team at Wells Fargo. As a key member of our team, you will be responsible for leading the development and execution of complex digital business plans, programs, and initiatives that drive business outcomes.Key Responsibilities:Lead the development and...

  • Strategic Consulting Director

    3 weeks ago

    Irving, Texas, United States Vizient Full time

    Job SummaryWe are seeking a highly skilled and experienced Consulting Director to join our team at Vizient. As a key member of our Indirect Spend - Facilities and Construction team, you will be responsible for managing consulting engagements and driving customer value through insightful analytics and project management expertise.Key ResponsibilitiesDevelop...

  • Strategic Consulting Director

    4 weeks ago

    Irving, Texas, United States Vizient Full time

    About the Role:We are seeking a highly experienced and skilled Strategic Consulting Director to join our team at Vizient. As a key member of our Indirect Spend - Facilities and Construction team, you will play a critical role in managing consulting engagements and driving business growth.Key Responsibilities:Lead work efforts to drive customer value through...

  • Strategic Consulting Director

    2 weeks ago

    Irving, Texas, United States Vizient Full time

    About the Role:Vizient is seeking a highly skilled and experienced Consulting Director to join our team. As a key member of our Indirect Spend - Facilities and Construction team, you will be responsible for managing consulting engagements and driving customer value through insightful analytics and strategic planning.Key Responsibilities:Lead work efforts to...

  • Senior Lead Analytic Consultant

    4 weeks ago

    Irving, Texas, United States Wells Fargo Full time

    About This RoleWe are seeking a Senior Lead Analytic Consultant to join our Customer Remediation Verification (CRV) team within Enterprise Complaints Remediation (ECR). As a key member of our team, you will be responsible for conducting advanced data quality review and challenge for complex, high-risk, high-priority, non-model data analysis activities across...

  • Litigation Consultant

    4 weeks ago

    Irving, Texas, United States Sedgwick Full time

    About SedgwickSedgwick is a leading global provider of technology-enabled risk, benefits, and integrated business solutions. Our mission is to help organizations protect their employees, customers, and assets while minimizing business interruptions.Job SummaryWe are seeking a highly skilled Litigation Consultant to join our team. As a Litigation Consultant,...

  • IT Strategy Consultant

    1 month ago

    Irving, Texas, United States Gartner Full time

    About the Role:Gartner Consulting is an extension of Gartner's industry-leading IT research, providing the needed support to accelerate clients' achievement of their target outcomes. Leveraging Gartner's resources, we apply our industry-leading research to drive client success.Key Responsibilities:Develop effective strategies for sourcing products/services...

  • IT Strategy Consultant

    3 weeks ago

    Irving, Texas, United States Gartner Full time

    About the Role:Gartner Consulting is an extension of Gartner's industry-leading IT research, providing the necessary support to accelerate clients' achievement of their target outcomes. Leveraging Gartner's resources, we apply our industry-leading research to drive client success.Our Team:Our Sourcing & Spend Optimization team is the industry leader in...

  • Facilities Management Project Lead

    6 days ago

    Irving, Texas, United States Exela Technologies Full time

    Project OverviewThe ideal candidate will lead the planning, execution, and completion of complex facilities management projects, including building maintenance and facility consolidations. This role requires a strong background in facilities management and civil engineering projects, along with proven project management expertise.Key ResponsibilitiesManage...

Lead Regulatory Affairs Consultant

2 months ago

Irving, Texas, United States Abbott Full time

Abbott stands as a prominent leader in the healthcare sector, dedicated to enhancing the quality of life for individuals at every stage. Our extensive range of transformative technologies encompasses various healthcare domains, including diagnostics, medical devices, nutritionals, and branded generic medicines. With a workforce of 114,000 professionals, we serve communities across more than 160 nations.

Position Overview: Senior Regulatory Affairs Specialist

About Abbott

At Abbott, you will engage in meaningful work, experience personal and professional growth, and enjoy a supportive environment that values your individuality. Our offerings include:

  • Opportunities for career advancement within a global organization.
  • Comprehensive medical coverage for employees through the Health Investment Plan (HIP) PPO.
  • A robust retirement savings plan with significant employer contributions.
  • Tuition reimbursement programs and educational benefits to facilitate your pursuit of higher education.
  • A workplace recognized globally for its commitment to diversity and inclusion.

Role Responsibilities:

As a key member of the Transfusion Medicine regulatory team, you will:

  • Contribute to regulatory activities essential for product market entry and ongoing support of both hardware and software.
  • Collaborate with cross-functional teams to enhance the efficiency of regulatory deliverables.
  • Investigate and assess the regulatory landscape to formulate strategies for product approvals in both domestic and international markets.
  • Engage with country-specific regulatory experts to gather insights during product development.
  • Assist the Compliance Team during internal and external audits.
  • Prepare and oversee the documentation required for global registration.
  • Support the development and review of Standard Operating Procedures (SOPs) and provide regulatory insights for product lifecycle management.
  • Communicate submission requirements to core product teams and participate in risk-benefit analyses.
  • Compile and submit regulatory documents to authorities, ensuring compliance with evolving regulations.
  • Negotiate with regulatory agencies to facilitate the approval process.
  • Review promotional materials and labeling for regulatory compliance.
  • Monitor product safety issues and report them to relevant regulatory bodies.

Qualifications:

Required:

  • Bachelor's degree in a scientific or medically related field.
  • A minimum of 3-4 years of experience in a regulated industry.
  • 2-3 years of experience in regulatory affairs or related fields.

Preferred:

  • Master's degree in regulatory affairs or a related discipline.
  • Regulatory Affairs Certification (RAC).
  • Experience with FDA submissions and device support.

Abbott is an Equal Opportunity Employer, committed to fostering a diverse workforce. We provide reasonable accommodations to qualified individuals with disabilities.