Current jobs related to Regulatory Affairs Manager - Saint Paul - Abbott

  • 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...

  • 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...

  • 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...

  • 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...

  • 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...

  • Senior Regulatory Affairs Specialist

    3 months ago

    Saint Paul, United States Collabera Full time

    Job DescriptionJob Description·         Perform assigned regulatory activities including submissions/responses to country authorities. Daily Responsibilities - Job Description suppliers should use:·         Plan and prepare documents for EU MDR Technical File original submissions or responses to Notified Body for existing Technical Files...

  • 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...

  • Senior Regulatory Affairs Specialist

    2 days ago

    Saint Paul, Minnesota, United States Abbott Full time

    The OpportunityWe 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 ResponsibilitiesDevelop and implement regulatory strategies to ensure compliance with global regulations.Provide regulatory input...

  • HYBRID - Regulatory Affairs Associate

    3 months ago

    Saint Paul, United States Russell Tobin & Associates Full time

    What are we looking for in our HYBRID - Regulatory Affairs Associate? The Scientific Team at Russell Tobin & Associates is supporting a world-class material science organization that has an opening for a HYBRID Regulatory Affairs Associate near St. Paul, MN!   Responsibilities Support global regulatory activities Product compliance and...

  • HYBRID - Regulatory Affairs Associate

    1 month ago

    Saint Paul, United States Russell Tobin & Associates Full time

    What are we looking for in our HYBRID - Regulatory Affairs Associate? The Scientific Team at Russell Tobin & Associates is supporting a world-class material science organization that has an opening for a HYBRID Regulatory Affairs Associate near St. Paul, MN! ResponsibilitiesSupport global regulatory activitiesProduct compliance and...

  • Senior Regulatory Affairs Specialist – Structural Heart

    2 months ago

    Saint Paul, United States Abbott Full time

    The Opportunity We are recruiting for a Senior Regulatory Affairs Specialist to join our team on-site in St. Paul, MN.This new team member will provide support for the regulatory department to ensure efficient and compliant business processes and environment. The individual may execute tasks and play a consultative role by partnering across business...

  • 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...

  • Regulatory Affairs Specialist

    1 month ago

    Saint Joseph, United States Meet Full time

    Our client is seeking a highly skilled and motivated Senior Specialist in US Regulatory Affairs Operations. This position, based in either St. Joseph, MO or Athens, GA, offers a unique opportunity to be a vital part of a dynamic team, focusing on regulatory compliance and product maintenance for veterinary products.Key Responsibilities:Independently manage...

  • HYBRID - Regulatory Affairs Associate

    2 months ago

    Saint Paul, United States RTA US Full time

    Job DescriptionJob DescriptionThe Scientific Team at Russell Tobin & Associates is supporting a world-class material science organization that has an opening for a HYBRID Regulatory Affairs Associate near St. Paul, MN! ResponsibilitiesSupport global regulatory activitiesProduct compliance and certificationAuthoring and updating Safey Data Sheets and other...

  • Regulatory Affairs Manager

    3 months ago

    St. Paul, United States Abbott Laboratories Full time

    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 114,000 colleagues serve people in more than 160 countries.About...

  • Senior Regulatory Affairs Specialist – Structural Heart

    2 months ago

    St. Paul, United States Abbott Laboratories Full time

    Working at AbbottAt Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:Career development with an international company where you can grow the career you dream of.Free medical coverage for employees* via the Health Investment Plan (HIP) PPOAn excellent...

  • Senior Regulatory Affairs Specialist – Structural Heart

    2 months ago

    St. Paul, United States Abbott Laboratories Full time

    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 114,000 colleagues serve people in more than 160 countries.Working at...

  • 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...

  • Sr Regulatory Analyst

    4 months ago

    Saint Paul, United States Travelers Full time

    Who Are We? Taking care of our customers, our communities and each other. That’s the Travelers Promise. By honoring this commitment, we have maintained our reputation as one of the best property casualty insurers in the industry for over 160 years. Join us to discover a culture that is rooted in innovation and thrives on collaboration. Imagine...

Regulatory Affairs Manager

3 months ago

Saint Paul, United States Abbott Full time

The Opportunity

We are recruiting for a Regulatory Affairs Manager to join our team in St. Paul, MN. In this role, you will combine knowledge of scientific, regulatory and business issues to enable products to meet required legislation. You will be responsible for managing a small team overseeing the mechanical heart valve and annuloplasty ring product portfolio, creating robust global regulatory strategies, working with cross-functional teams as the regulatory SME, compiling regulatory submissions, and ensuring data is effectively presented for the registration of products worldwide.

What You’ll Work On

Managing a team of regulatory specialists Represent Regulatory Affairs on cross functional project teams and provide strategic input and technical guidance on regulatory requirements for Class III and Class II medical devices. Assess the acceptability of documentation for Class III and Class II medical device submissions and effectively communicate regulatory guidance. Compile, prepare, review and submit Class III and Class II medical device submissions to regulatory agencies. Interact, answer questions and negotiate with regulatory agencies during the submission review process to obtain submission approval. Evaluate proposed design and manufacturing changes for regulatory impact and implement any required regulatory action. Utilize technical regulatory skills to propose strategies on complex issues. Monitor regulatory landscape for impact to company products and help to develop solutions to regulatory obstacles, with other members of regulatory and related teams. Ensure compliance with product post marketing approval requirements. Review product labeling and promotional material to ensure compliance with relevant regulatory requirements. Help to develop regulatory strategy for Class III and Class II medical devices, with other regulatory team members. Provide regulatory support for internal and external audits.

Required Qualifications

Bachelor’s Degree or an equivalent combination of education and work experience 8+ years’ experience in the medical device industry, with 5 of those years related to the preparation of FDA submissions (PMA, IDE, 510(k)) for Class I, II, and III medical devices. Ability to work effectively on project teams and be able to juggle multiple and competing priorities. Scientific writing experience. Strong verbal, written and presentation skills with the ability to effectively communicate at multiple levels in the organization.

Preferred Qualifications

Bachelor’s Degree in Engineering, Medical, Science or related discipline. Advanced degree Experience with EU, Canada, Japan, China, Australia and other international medical device regulations and submissions Experience collaborating with cross-functional teams in a geographically diverse, matrixed organization. Supervisory experience Previous experience with Class III EU MDR and PMA submissions Proficient with MS Office (Word, Excel, Outlook).

*