Senior Regulatory Affairs Specialist

2 days ago

Saint Paul, Minnesota, United States Abbott Full time

The Opportunity

We are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team at Abbott. This individual will play a critical role in ensuring the regulatory compliance of our medical products worldwide.

Key Responsibilities

  • Develop and implement regulatory strategies to ensure compliance with global regulations.
  • Provide regulatory input to product lifecycle planning and ensure that products meet regulatory requirements.
  • Assist in the development of regional regulatory strategies and update strategies based on regulatory changes.
  • Monitor and evaluate regulatory history and background of class, disease, therapeutic, and diagnostic contexts to assess regulatory implications for approval.
  • Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval.
  • Maintain annual licenses, registrations, listings, and patent information.
  • Submit and review change controls to determine the level of change and consequent submission requirements.

Required Qualifications

  • Bachelor's Degree or an equivalent combination of education and experience.
  • 3-4 years' experience in a regulated industry (e.g., medical products, nutritionals).
  • 2-3 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
  • Effectively communicate, prepare, and negotiate both internally and externally with various regulatory agencies.
  • Ability to work in a highly matrixed and geographically diverse environment.

Preferred Qualifications

  • Master's Degree in Regulatory Affairs preferred and may be used in lieu of direct regulatory experience.
  • 5+ years' experience in Medical Device industry.
  • 3-5 years of regulatory experience.
  • Think analytically with good problem-solving skills.
  • 510(k), PMA, or other international regulatory submission experience.

  • Senior Regulatory Affairs Specialist

    3 weeks ago

    Saint Paul, Minnesota, United States Abbott Full time

    About the RoleWe are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team at Abbott. This individual will play a critical role in ensuring the compliance of our medical devices with regulatory requirements worldwide.Key ResponsibilitiesDevelop and implement regulatory strategies to ensure compliance with global regulations and...

  • Regulatory Affairs Specialist

    4 days ago

    Saint Paul, Minnesota, United States Katalyst Healthcares and Life Sciences Full time

    Regulatory Affairs SpecialistKatalyst Healthcares and Life Sciences is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will be responsible for providing regulatory guidance to cross-functional partners and developing global regulatory strategies for new and modified medical devices.Key...

  • Senior Regulatory Affairs Specialist

    5 days ago

    Saint Paul, Minnesota, United States Abbott Laboratories Full time

    About the RoleAbbott Laboratories is seeking a highly skilled Senior Regulatory Affairs Specialist to join our team in St. Paul, MN. As a key member of our regulatory department, you will play a critical role in ensuring efficient and compliant business processes and environment.Key ResponsibilitiesAssist in the development and review of Standard Operating...

  • Regulatory Affairs Specialist

    1 week ago

    Saint Paul, Minnesota, United States Abbott Full time

    The OpportunityWe are seeking a highly skilled Senior Regulatory Affairs Specialist to support our regulatory department in St. Paul, MN. This role will provide critical support for the development and implementation of regulatory strategies to ensure compliance with global regulations.Key ResponsibilitiesDevelop and implement regulatory strategies to ensure...

  • Regulatory Affairs Specialist

    3 days ago

    Saint Paul, Minnesota, United States Abbott Laboratories Full time

    About Abbott LaboratoriesAbbott Laboratories 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 MissionOur business purpose is...

  • Hybrid Regulatory Affairs Specialist

    4 weeks ago

    Saint Paul, Minnesota, United States RTA US Full time

    Job OverviewJoin the Scientific Team at RTA US, where we are partnering with a prestigious material science organization seeking a Hybrid Regulatory Affairs Specialist.Key ResponsibilitiesAssist in global regulatory initiativesEnsure product compliance and certificationDraft and revise Safety Data Sheets and other regulatory documentationPerform additional...

  • Lead Regulatory Affairs Specialist

    4 weeks ago

    Saint Paul, Minnesota, United States Travelers Full time

    About Us At Travelers, we prioritize the well-being of our clients, communities, and each other. This commitment has solidified our standing as a premier property casualty insurer for over 160 years. Join our innovative culture that thrives on teamwork and collaboration. Envision a career where you truly enjoy what you do and where you do it. Job...

  • Regulatory Affairs Manager

    5 days ago

    Saint Paul, Minnesota, United States Abbott Laboratories Full time

    About Abbott LaboratoriesAbbott Laboratories 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.We're always looking towards the...

  • Advanced Regulatory Compliance Consultant

    3 weeks ago

    Saint Paul, Minnesota, United States Travelers Full time

    Who Are We? At Travelers, we prioritize the well-being of our customers, communities, and each other. This commitment has solidified our status as a leading property casualty insurer for over 160 years. Join us to experience a culture driven by innovation and collaboration, where you can truly enjoy your work and workplace. Job Category Actuarial...

  • Senior Biocompatibility Specialist

    2 weeks ago

    Saint Paul, Minnesota, United States Abbott Laboratories Full time

    About Abbott LaboratoriesAbbott Laboratories is a leading global healthcare company that develops and manufactures innovative medical devices, diagnostics, and pharmaceuticals. Our mission is to help people live more fully at all stages of life.Job SummaryWe are seeking a highly experienced Senior Biocompatibility Specialist to join our team at Abbott...

  • Senior Principal Clinical Scientist

    5 days ago

    Saint Paul, Minnesota, United States Abbott Laboratories Full time

    About the RoleAbbott Laboratories 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.We are seeking a highly skilled Senior...

  • Senior Compliance Analyst

    3 weeks ago

    Saint Paul, Minnesota, United States Travelers Full time

    About Us At Travelers, we prioritize the well-being of our clients, communities, and employees. Our commitment to excellence has established us as a leading property casualty insurer for over 160 years. Join our innovative and collaborative culture where you can thrive in your career. Job Category Regulatory Affairs Compensation Overview The...

  • Licensed Practical Nurse

    2 weeks ago

    Saint Paul, Minnesota, United States Sunlight Senior Living Full time

    Job SummarySunlight Senior Living is seeking a highly skilled and compassionate Licensed Practical Nurse (LPN) to join our team as a Senior Care Specialist. In this critical role, you will be responsible for ensuring the health and safety of our clients, while also providing exceptional care and support.Key ResponsibilitiesHealth and Safety Management:...

  • Senior Quality Assurance Specialist

    3 weeks ago

    Saint Paul, Minnesota, United States Hispanic Technology Executive Council Full time

    About Quality Assurance at Hispanic Technology Executive CouncilOur Quality Assurance team plays a vital role in ensuring that our products and services meet the highest standards of quality and regulatory compliance. As a Senior Quality Assurance Specialist, you will be responsible for developing and implementing quality policies, procedures, and processes...

  • Senior Quality Assurance Specialist

    2 days ago

    Saint Paul, Minnesota, United States Hispanic Technology Executive Council Full time

    Job SummaryWe are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Cardinal Health. As a key member of our quality team, you will be responsible for ensuring that our products and services meet the highest standards of quality and regulatory compliance.Key ResponsibilitiesDevelop and implement quality policies, procedures, and...

  • Senior Biocompatibility Specialist

    5 days ago

    Saint Paul, Minnesota, United States Abbott Laboratories Full time

    About the RoleAbbott Laboratories is a global healthcare leader that empowers individuals to live their best lives. Our diverse portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines.We're seeking a highly skilled Senior...

  • Culinary Specialist

    4 weeks ago

    Saint Paul, Minnesota, United States Sunlight Senior Living Full time

    About Sunlight Senior Living At Sunlight Senior Living, we are dedicated to providing a warm and nurturing environment for our residents. Our commitment to excellence extends to every aspect of their lives, including the culinary experience. Culinary Specialist We are seeking a passionate and skilled Culinary Specialist to join our team. In this role, you...

  • Senior Principal Clinical Scientist

    4 days ago

    Saint Paul, Minnesota, United States Abbott Laboratories Full time

    About Abbott LaboratoriesAbbott 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 MissionOur mission is to restore health and...

  • Senior Quality Assurance Specialist

    2 days ago

    Saint Paul, Minnesota, United States Cardinal Health Full time

    Job SummaryWe are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Cardinal Health. In this role, you will be responsible for ensuring the quality of our products and services, developing and implementing quality policies and procedures, and providing oversight of production and manufacturing activities.Key...

  • Regulatory Compliance Specialist

    1 week ago

    Saint Cloud, Minnesota, United States Centra Care Full time

    {"title": "Regulatory Compliance Specialist", "content": "Job SummaryCentraCare is seeking a highly skilled Regulatory Compliance Specialist to join our research team. In this role, you will be responsible for ensuring compliance with Federal, Sponsor, and Institutional Review Board (IRB) regulatory guidelines. Your expertise will be crucial in ensuring the...