Regulatory Operations Coordinator

5 days ago

Saint Paul, Minnesota, United States Abbott Laboratories Full time
About Abbott Laboratories

Abbott is a leading global healthcare company that develops innovative life-changing technologies to help people live more fully at all stages of life.

We have a portfolio of life-changing products and services in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in over 160 countries around the world.

Job Summary:

This role is responsible for performing specialized level work assignments and/or analyses, evaluation, preparation and general support of global regulatory activities. As a Regulatory Operations Specialist I, you will be part of our team that aims to restore health and improve quality of life through device and management solutions for structural heart disease.

Key Responsibilities:
  • Manage Product Release Authorization (PRA) activities to enable shipment of product, maintain accurate master data, ZFIN selection, PRA Checklists, and proper approvers for assigned regions.
  • Serve as a regulatory representative reviewing and analyzing GTS blocked orders and coordinate activities to resolve issues, reporting status to management on high priority product release activities.
  • Maintain basic understanding of product lines and organize product information for internal procedures, reporting, quality plans, and audit needs.
  • Understand and utilize Windchill and other business systems for change control, documentation control, and other Regulatory Affairs interactions.
  • Complete other daily support tasks when assigned, such as data clean up, quality system documentation, training, audit support, CAPA, system enhancements, etc.
  • Represent Regulatory Operations in cross-functional interactions with Supply Chain, Customer Support, Quality, Marketing, In-Country affiliates and IT.
  • Supports all business segment initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
Requirements:
  • Bachelor's or associate degree within STEM field preferred.
  • Related experience preferably a minimum of one year in Medical Device industry.
  • Experience with ERP and/or PLM systems such as SAP and/or Windchill.
  • Knowledge with Medical Device Quality Management Systems (QMS) and Good Documentation Practice (GDP).
  • Proficient with MS Office suite (Word, Excel, Outlook).
  • Ability to work in highly matrixed and geographically diverse business environment.
  • Strong organizational and follow-up skills, as well as attention to detail.
  • Multitasks, prioritizes and meets deadlines in timely manner.
Estimated Salary Range: $48,000 - $96,000 per year.

Please note that salary may vary based on specific location.

  • Regulatory Operations Professional

    2 weeks ago

    Saint Paul, Minnesota, United States Abbott Laboratories Full time

    Discover a fulfilling career with Abbott Laboratories, a global healthcare leader dedicated to improving people's lives.About UsWe are a diverse team of professionals working together to develop life-changing technologies that make a meaningful difference in the world. Our portfolio spans diagnostics, medical devices, nutritionals, and branded generic...

  • Regulatory Operations Specialist I

    2 weeks ago

    Saint Paul, Minnesota, United States Abbott Laboratories Full time

    Abbott Laboratories is a leading healthcare company that offers diverse opportunities for growth and development. Our team of professionals works together to deliver innovative solutions that improve people's lives.We are seeking a Regulatory Operations Specialist I to join our St. Paul, MN location. As a member of our team, you will be responsible for...

  • Regulatory Operations Specialist I

    6 days ago

    Saint Paul, Minnesota, United States Abbott Laboratories Full time

    About Abbott LaboratoriesAbbott Laboratories is a global leader in healthcare, dedicated to improving lives through innovative medical technologies and treatments.Job OverviewWe are seeking a highly skilled Regulatory Operations Specialist I to join our team in St. Paul, MN. As a key member of our Regulatory Affairs department, you will play a critical role...

  • Regulatory Affairs Operations Specialist I

    3 days ago

    Saint Paul, Minnesota, United States Abbott Laboratories Full time

    About UsAbbott Laboratories is a leading global healthcare company dedicated to improving lives through innovative technologies, products and services. We are committed to helping people live more fully at all stages of life.Our MissionWe strive to be a trusted partner for our customers, patients and employees by delivering high-quality products and services...

  • Global Regulatory Compliance Specialist

    4 weeks ago

    Saint Paul, Minnesota, United States Abbott Full time

    The OpportunityAbbott is seeking a highly skilled Regulatory Affairs Operations Specialist I to join our team at our St. Paul, MN location.About the RoleThis role involves performing specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for worldwide regulatory registration.You will ensure products and...

  • Regulatory Affairs Operations Specialist I

    6 days ago

    Saint Paul, Minnesota, United States Abbott Laboratories Full time

    Discover a rewarding career at Abbott Laboratories, a global leader in healthcare innovation. We are seeking a highly skilled Regulatory Affairs Operations Specialist I to join our team in St. Paul, MN.

  • Regulatory Affairs Expert for Medical Device Development

    3 weeks ago

    Saint Paul, Minnesota, United States Abbott Full time

    We are recruiting a highly skilled Senior Regulatory Affairs Specialist to join our team at Abbott in St. Paul, MN. This individual will play a crucial role in ensuring efficient and compliant business processes and environment within the regulatory department.About the RoleThis position involves providing support for the regulatory department by executing...

  • Operations Coordinator

    3 weeks ago

    Saint Paul, Minnesota, United States The Right Staff, LLC Full time

    The Right Staff, LLC seeks an experienced Administrative Assistant to start ASAP.We are a mission-driven organization partnering with a leading non-profit to find the perfect candidate for this role.About the Role:This is a dynamic position requiring strong organizational and communication skills. The successful candidate will be responsible for providing...

  • Business Operations Coordinator

    3 weeks ago

    Saint Paul, Minnesota, United States Pk Property Services Llc Full time

    About Pk Property Services Llc:We are a market leader in facility services, supplying exceptional quality in custodial services, project floor maintenance, landscaping, snow plowing, and more.Job Summary:The Business Operations Coordinator assists critical functions to the success of our company by accomplishing the below tasks:Entering sales orders into our...

  • Office Operations Coordinator

    4 days ago

    Saint Paul, Minnesota, United States LanceSoft Inc Full time

    About the RoleWe are looking for a dedicated Office Operations Coordinator to join our LanceSoft Inc team. This full-time position involves maintaining the cleanliness and organization of our office space, ensuring a comfortable and productive work environment for our employees.Key Responsibilities:Cleaning and organizing breakrooms, coffee machines, and...

  • Administrative Support Specialist

    3 weeks ago

    Saint Paul, Minnesota, United States State of Minnesota Full time

    Job OverviewThis is a dynamic opportunity to join the Health Promotion & Chronic Disease (HPCD) Division at the State of Minnesota as an Administrative Support Specialist - Operations Coordinator.The successful candidate will provide lead administrative support and coordination for operations and projects, ensuring seamless day-to-day functioning. This role...

  • Service and Operations Coordinator

    3 weeks ago

    Saint Paul, Minnesota, United States Allstate Peterbilt Group Full time

    Job Summary: As a Service Advisor with Allstate Peterbilt Group, you will be responsible for overseeing the day-to-day operations of our service department. This includes ensuring effective communication with customers, monitoring job schedules, and maintaining current knowledge on job times, pricing, and flat rates.Key Responsibilities:Assist in overseeing...

  • Financial Operations Coordinator

    3 weeks ago

    Saint Paul, Minnesota, United States Pathways to Community Full time

    Job OverviewPathways to Community is seeking a skilled Financial Operations Coordinator to join their finance team. This role offers a competitive salary and comprehensive benefits package.Salary: $45,000 - $55,000 per annumKey ResponsibilitiesManage accounts payable and receivable processesProcess expense reports and maintain vendor portalsMaintain...

  • Administrative Operations Coordinator

    2 weeks ago

    Saint Paul, Minnesota, United States Wold Architects Inc Full time

    Job DescriptionWe are seeking a skilled Senior Administrative Coordinator to join our team at Wold Architects and Engineers in St. Paul, Minnesota.This role is responsible for providing administrative support to our architectural and engineering teams, including project managers and staff. Key responsibilities include formal correspondence, receptionist...

  • Logistics Coordinator

    2 weeks ago

    Saint Paul, Minnesota, United States US Foods, Inc. Full time

    Job SummaryThis position is responsible for coordinating logistics operations, ensuring efficient movement of trailers and equipment. A valid CDL Class A license and strong communication skills are required.About US Foods, Inc.US Foods, Inc. is a leading food distributor with a commitment to excellence in customer service. Our drivers play a critical role in...

  • Operations Coordinator

    2 weeks ago

    Saint Paul, Minnesota, United States Budget Towing Inc Full time

    At Budget Towing Inc, we are seeking an experienced Operations Coordinator to join our team. This is a part-time night shift position that requires excellent communication and organizational skills.The ideal candidate will have dispatching experience and knowledge of the Twin Cities and surrounding areas. They will be responsible for multitasking between...

  • Dessert Holdings Inc. Legal Operations Manager

    2 weeks ago

    Saint Paul, Minnesota, United States Dessert Holdings Inc. Full time

    About Us: Dessert Holdings Inc. is a leading North American premium dessert company, recognized for its unparalleled dessert experiences in both retail and foodservice sectors.We're Hiring: A talented Legal Operations Manager to support our growing legal team!Job Description:We're seeking an experienced professional with a strong background in legal document...

  • Market Operations Coordinator

    3 weeks ago

    Saint Paul, Minnesota, United States Open Cupboard Full time

    Company Overview:Today's Harvest is a free market providing fresh produce, meat, dairy, and bakery items rescued daily from local grocery stores, farms, and other partners. This initiative is part of Open Cupboard, which operates programs improving food access in the East Metro.

  • Industrial Operations Director

    3 weeks ago

    Saint Paul, Minnesota, United States GPAC Full time

    A renowned family-owned food manufacturer in the Midwest is seeking an exceptional Industrial Operations Director to oversee their state-of-the-art facility.This position presents a unique opportunity to lead a dedicated team, fostering operational excellence and team development while driving business growth.As the key leader, you will be responsible for...

  • Financial Transaction Coordinator

    22 hours ago

    Saint Paul, Minnesota, United States Blue Star Partners LLC Full time

    Job OverviewBlue Star Partners LLC is seeking a Payroll Associate I to support our financial operations. This role is responsible for ensuring the accurate and timely payment of various salary components, including but not limited to vacation pay, overtime, and bonuses.Key Duties and Responsibilities:Process monthly payroll for employees, ensuring accuracy...