Senior Regulatory Affairs Specialist

1 week ago

Atlanta, Georgia, United States Abbott Full time
About Abbott

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.

Job Description

We are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team in Atlanta, GA. As a key member of our regulatory department, you will play a critical role in ensuring efficient and compliant business processes and environment.

Key Responsibilities
  • Act as a regulatory representative on core product development teams, communicating regulatory requirements and impact of regulations to project teams.
  • Develop global regulatory strategies for new and modified products.
  • Prepare and submit PMA and IDE Submissions and Supplements.
  • Work with international affiliates to compile and submit international product registrations and licensing applications.
  • Interpret new or existing regulatory requirements as they relate to the product portfolio and regulatory and quality system procedures.
  • Review and advise on labeling, product claims, marketing brochures, and other publications to ensure compliance with regulations.
  • Maintain annual licenses, registrations, and listing information.
  • Assist with compliance to product post-marketing approval requirements.
  • Support the product release process by creating GTS licenses or reviewing and approving requests for product release.
  • Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
Requirements
  • Bachelor's Degree in a related field 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.
  • Strong written, verbal, presentation, and organizational skills. Ability to write and edit technical documents.
  • Exercise good and ethical judgment within policy and regulations.
  • Ability to work effectively on project teams and maintain project plans and timelines.
  • Strong analytical and problem-solving skills.
Preferred Qualifications
  • 5-7 years' experience in a regulated industry with a minimum of 3 of those years directly related to Class III Medical Devices.
  • Master's degree in Regulatory Affairs and may be used in lieu of direct regulatory experience.
  • Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society).
  • Must be able to manage multiple and competing priorities and manage programs with minimal oversight.
  • Working knowledge of QSR, ISO, and EN standards. Strong working knowledge of regulatory requirements for US, EU (EU MDR), and other international geographies.
  • Experience with medical device software requirements and software regulations.
  • Ability to identify risk areas and escalate issues as appropriate.
About the Role

This is a challenging and rewarding role that requires a strong understanding of regulatory requirements and a ability to work effectively in a fast-paced environment. If you are a motivated and detail-oriented individual with a passion for regulatory affairs, we encourage you to apply.

Abbott is an Equal Opportunity Employer, committed to employee diversity. We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.

  • Regulatory Affairs Specialist

    2 weeks ago

    Atlanta, Georgia, United States EPM Scientific Full time

    Job Title: Principal Regulatory Affairs SpecialistWe are seeking a highly skilled Principal Regulatory Affairs Specialist to join our team at EPM Scientific. As a key member of our regulatory affairs team, you will play a critical role in ensuring compliance with regulatory requirements and supporting the development of our medical device and diagnostics...

  • Regulatory Affairs Specialist

    4 weeks ago

    Atlanta, Georgia, United States Accordance Search Group Full time

    Job Title: Principal Regulatory Affairs SpecialistWe are seeking a highly skilled Principal Regulatory Affairs Specialist to join our team at Accordance Search Group.Job SummaryThe Principal Regulatory Affairs Specialist will provide regulatory guidance to cross-functional partners, develop global regulatory strategies for new and modified Class III devices,...

  • Regulatory Affairs Specialist

    4 weeks ago

    Atlanta, Georgia, United States EPM Scientific Full time

    Job Title: Principal Regulatory Affairs SpecialistAbout the Role:EPM Scientific is seeking a highly skilled Principal Regulatory Affairs Specialist to support the growth of our medical device and diagnostics portfolio. As a key member of our regulatory team, you will play a critical role in ensuring compliance with FDA and international regulations.Key...

  • Regulatory Affairs Specialist

    2 weeks ago

    Atlanta, Georgia, United States EPM Scientific Full time

    EPM Scientific is seeking a Principal Regulatory Affairs Specialist to support their growing product portfolio. This is an exciting opportunity to join an innovative company working on breakthrough products. Responsibilities: * Act as the regulatory representative on core product development teams and provide input related to FDA and international product...

  • Regulatory Affairs Specialist

    3 weeks ago

    Atlanta, Georgia, United States Accordance Search Group Full time

    Principal Regulatory Affairs SpecialistAccordance Search Group is seeking a highly skilled Principal Regulatory Affairs Specialist to join our team in Atlanta, GA.The ideal candidate will have a strong background in regulatory affairs, with experience in developing global regulatory strategies for new and modified Class III devices. They will be responsible...

  • Regulatory Affairs Specialist

    3 weeks ago

    Atlanta, Georgia, United States Accordance Search Group Full time

    Job Title: Principal Regulatory Affairs SpecialistAccordance Search Group is seeking a highly skilled Principal Regulatory Affairs Specialist to join our team. As a key member of our regulatory affairs team, you will be responsible for providing regulatory guidance to cross-functional partners, developing global regulatory strategies for new and modified...

  • Regulatory Affairs Specialist

    4 weeks ago

    Atlanta, Georgia, United States Abbott Laboratories company Full time

    About the RoleWe are seeking a highly skilled Principal Regulatory Affairs Specialist to join our team at Abbott Laboratories. As a key member of our regulatory affairs team, you will play a critical role in ensuring the compliance of our medical devices with regulatory requirements.Key ResponsibilitiesProvide regulatory guidance to cross-functional partners...

  • Regulatory Affairs Specialist

    4 weeks ago

    Atlanta, Georgia, United States Accordance Search Group Full time

    Principal Regulatory Affairs SpecialistAccordance Search Group is seeking a highly skilled Principal Regulatory Affairs Specialist to join our team in Atlanta, GA. As a key member of our regulatory team, you will be responsible for providing regulatory guidance to cross-functional partners, developing global regulatory strategies for new and modified Class...

  • Regulatory Affairs Specialist

    4 weeks ago

    Atlanta, Georgia, United States Accordance Search Group Full time

    Accordance Search Group is seeking a highly skilled Principal Regulatory Affairs Specialist to join our team in Atlanta, GA.The ideal candidate will have a strong background in regulatory affairs, with experience in developing global regulatory strategies for new and modified Class III devices. They will be responsible for providing regulatory guidance to...

  • Senior Director, Global Regulatory Affairs Strategy

    4 weeks ago

    Atlanta, Georgia, United States Daiichi Sankyo, Inc. Full time

    Job Title: Senior Director, Global Regulatory Affairs StrategyAbout the RoleDaiichi Sankyo, Inc. is seeking a highly experienced Senior Director to lead our Global Regulatory Affairs Strategy team. As a key member of our organization, you will be responsible for developing and implementing global regulatory strategies to ensure compliance with regulatory...

  • Regulatory Affairs Specialist II

    4 weeks ago

    Atlanta, Georgia, United States Abbott Laboratories company 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.Job SummaryWe are seeking a highly skilled...

  • Product Stewardship and Regulatory Affairs Specialist

    3 days ago

    Atlanta, Georgia, United States Kemira Full time

    About KemiraKemira is a global leader in sustainable chemistry, driving human progress and quality of life through innovative solutions. With a rich history spanning over 100 years, we've established ourselves as a trusted partner in the water-intensive industries. Our mission is to create chemistry with a purpose, better every day.Job SummaryWe're seeking a...

  • Regulatory Affairs Specialist II Heart Failure

    4 weeks ago

    Atlanta, Georgia, United States Abbott Laboratories company Full time

    Job Title: Regulatory Affairs Specialist II Heart FailureAbbott 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.As a...

  • Regulatory Affairs Manager

    3 weeks ago

    Atlanta, Georgia, United States Proclinical Staffing Full time

    Job Title: Manager, Regulatory Affairs LabelingProclinical Staffing is seeking a highly skilled Manager, Regulatory Affairs Labeling to join our team. As a key member of our regulatory affairs team, you will be responsible for leading the development of new labeling content and managing the creation and maintenance of all US product labeling components.Key...

  • Regulatory Affairs Specialist II

    2 weeks ago

    Atlanta, Georgia, United States Abbott Full time

    About AbbottAbbott 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,...

  • Regulatory Affairs Director

    4 weeks ago

    Atlanta, Georgia, United States Daiichi Sankyo, Inc. Full time

    Unlock Your Potential in Regulatory AffairsDaiichi Sankyo Group is a pioneering pharmaceutical company dedicated to delivering innovative therapies that improve patient outcomes. As a key player in the industry, we're committed to pushing the boundaries of science and technology to address unmet medical needs.About the RoleWe're seeking an experienced...

  • Regulatory Affairs Director

    4 days ago

    Atlanta, Georgia, United States Daiichi Sankyo, Inc. Full time

    Regulatory Affairs RoleThis position involves developing and implementing US regulatory strategies for assigned projects, collaborating with FDA, and preparing submissions to ensure timely and quality approvals.About Daiichi SankyoDaiichi Sankyo Group is a pharmaceutical company dedicated to creating innovative therapies to improve standards of care and...

  • Regulatory Affairs Specialist II – Heart Failure

    4 weeks ago

    Atlanta, Georgia, United States Abbott Laboratories Full time

    About the RoleAbbott Laboratories is seeking a highly skilled Regulatory Affairs Specialist II to join our Heart Failure Division in Atlanta, GA. As a key member of our team, you will play a critical role in ensuring the regulatory compliance of our products and procedures.Key ResponsibilitiesPrepare and submit regulatory applications to achieve departmental...

  • Regulatory Affairs Specialist II – Heart Failure

    4 weeks ago

    Atlanta, Georgia, United States Abbott Laboratories Full time

    About the RoleAbbott Laboratories is seeking a highly skilled Regulatory Affairs Specialist II to join our Heart Failure Division in Atlanta, GA. As a key member of our team, you will play a critical role in ensuring the regulatory compliance of our medical devices.Key ResponsibilitiesPrepare and submit regulatory applications to FDA and international...

  • Global Regulatory Affairs Labeling Expert

    3 weeks ago

    Atlanta, Georgia, United States Daiichi Sankyo, Inc. Full time

    Job SummaryDaiichi Sankyo, Inc. is seeking a highly skilled Global Regulatory Affairs Labeling Expert to join our team. As a key member of our Regulatory Affairs department, you will be responsible for providing strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs).ResponsibilitiesAct as point of...