Regulatory Affairs Professional

1 week ago

Atlanta, Georgia, United States Abbott Laboratories Full time

About Abbott

Abbott is a leading global healthcare company that helps people live more fully at all stages of life. Our portfolio of innovative technologies spans the spectrum of healthcare, with renowned businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines.

Our diverse workforce of 114,000 colleagues serves people in over 160 countries worldwide. At Abbott, you can make a meaningful impact, grow, and learn, take care of yourself and your family, be your authentic self, and live a full life.

Key Benefits

  • Career development with an international company where you can advance your career
  • Free medical coverage for employees via the Health Investment Plan (HIP) PPO
  • An excellent retirement savings plan with high employer contribution
  • Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit – an affordable and convenient path to obtaining a bachelor's degree
  • A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies globally by Fortune
  • A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists

The Opportunity

This Regulatory Affairs Specialist II role will work on-site out of our Atlanta, GA location in our Heart Failure Division. In Abbott's Heart Failure business, we are developing solutions to diagnose, monitor, and manage heart failure, enabling people to restore their health and pursue their lives.

Responsibilities

  1. Prepares robust regulatory applications (either for FDA or for international regulatory agencies) to achieve departmental and organizational objectives.
  2. Creates, reviews, and approves engineering changes.
  3. Acts as core team member providing review and analysis of applicable regulatory guidelines and project regulatory assessments as needed.
  4. Reviews and evaluates communications to ensure they convey all necessary detail and adhere to applicable regulatory standards, including those set by the FDA or other worldwide regulatory agencies, for various international affiliates.
  5. Maintains pertinent domestic and international medical device regulations to ensure submission requirements worldwide are current and up-to-date, and entered into regulatory submission databases and file systems.
  6. Eases distribution of information regarding such regulations and requirements, especially those that are new or modified, to appropriate personnel.
  7. May interface directly with FDA and other regulatory agencies.
  8. Supports the product release process by creating GTS licenses or reviewing and approving requests for product release.
  9. Reviews protocols and reports to support regulatory submissions.
  10. Supports all business segment initiatives identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
  11. Complies with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.

Requirements

  • Bachelor's Degree or an equivalent combination of education and work experience.
  • Minimum 3 years' related experience, including a minimum of two years of regulatory experience.
  • Experience with either 510(k) applications, PMA supplements, and US device regulations or with EU and other international medical device regulations and submissions.
  • Ability to work in a highly matrixed and geographically diverse business environment.
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment. Ability to leverage, manage, and/or engage others to accomplish projects.
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
  • Strong organizational and follow-up skills, as well as attention to detail.
  • Multitasks, prioritizes, and meets deadlines in a timely manner.

Estimated Salary Range: $57,300.00 - $114,700.00 per year

  • Director of Regulatory Affairs

    6 days ago

    Atlanta, Georgia, United States InsideHigherEd Full time

    We are seeking an experienced compliance expert to join our team as the Director of Regulatory Affairs.In this critical role, you will develop and maintain a comprehensive compliance program, ensuring adherence to all applicable laws and regulations.You will also provide guidance and support to departments, serve as the primary point of contact for...

  • Regulatory Affairs Specialist

    4 days ago

    Atlanta, Georgia, United States Kickr Design Full time

    About the Role: We are seeking a seasoned Regulatory Affairs Specialist to join our team and support the development, implementation, and management of our Quality Management System (QMS). As a key member of our team, you will ensure compliance with regulatory requirements for medical device design and development, consumer product development, and...

  • VP of Government and Regulatory Affairs

    1 week ago

    Atlanta, Georgia, United States New Millennium Technical Resources Full time

    About the RoleWe are seeking a seasoned professional to fill the position of VP of Government and Regulatory Affairs. The successful candidate will have extensive experience in leading teams, programs, and projects related to national security, regulations, and compliance.This executive will collaborate with cross-functional teams to advance business...

  • Regulatory Affairs Operations Director

    1 month ago

    Atlanta, Georgia, United States Lifelancer Full time

    About the RoleWe are seeking an experienced Regulatory Affairs Operations Director to lead our regulatory information management (RIM) program globally.The successful candidate will be a strategist, collaborator, and confident leader with a solid understanding of RIM and a passion for driving meaningful changes to support our current and future RIM goals.Key...

  • Regulatory Affairs Specialist

    4 weeks ago

    Atlanta, Georgia, United States CorDx Full time

    Job DescriptionAt CorDx, a pioneering biotechnology company, we seek an accomplished Regulatory Coordinator to contribute to our team's success. The ideal candidate will be responsible for planning and executing regulatory compliance activities, analyzing and interpreting industry and regulatory guidelines, and organizing necessary documentation.Key...

  • Director of Government and Regulatory Affairs

    5 days ago

    Atlanta, Georgia, United States New Millennium Technical Resources Full time

    Key ResponsibilitiesThe successful Director of Government and Regulatory Affairs will be responsible for providing leadership support to help position NMTR USA to offer unassailable National Security Solutions products and features in response to emerging regulations.Coordination with cross divisional colleagues to advance NSS business development pipeline...

  • Product Stewardship Specialist

    4 weeks ago

    Atlanta, Georgia, United States Kemira Full time

    Job OpportunityKemira is a leading global provider of sustainable chemistry solutions for water-intensive industries. Our mission is to drive progress and improve quality of life through innovative chemistry.The Product Stewardship and Regulatory Affairs team at Kemira plays a vital role in ensuring our products meet the highest standards of safety, quality,...

  • Regulatory Affairs Director: Global RIM and Tech Leader

    4 weeks ago

    Atlanta, Georgia, United States Lifelancer Full time

    About the JobAre you a seasoned regulatory affairs professional looking to lead a global team in managing complex information systems? Do you have expertise in regulatory information management (RIM) and technology, with a passion for driving strategic changes to support business goals?We are seeking a highly skilled Director, Regulatory Affairs Operations...

  • General Counsel

    4 days ago

    Atlanta, Georgia, United States Serenity Healthcare Full time

    Serenity Healthcare is a dynamic and growing company that is revolutionizing mental healthcare and transforming lives. We are seeking a talented General Counsel - Regulatory Affairs to join our team and help us navigate the complex regulatory landscape of the healthcare industry.Job ResponsibilitiesIn this role, you will be responsible for reviewing,...

  • Regulatory Affairs Manager

    6 days ago

    Atlanta, Georgia, United States InsideHigherEd Full time

    We are seeking an exceptional Regulatory Affairs Manager to join our team at Genesis Career Group. As a key member of our senior leadership team, you will be responsible for developing and implementing an effective compliance program.The Director of Compliance will be headquartered at Genesis Career Group's main offices in Atlanta, Georgia, with occasional...

  • Regulatory Affairs Specialist

    4 days ago

    Atlanta, Georgia, United States Kickr Design Full time

    About Our CompanyWe are a innovative and collaborative company that prides itself on having a unique culture. Our team consists of talented engineers who are passionate about creating high-quality products. We are seeking a Regulatory Affairs Specialist to join our team.ResponsibilitiesQMS Development and Oversight:Develop, implement, and maintain a robust...

  • Regulatory Affairs Labeling Expert

    4 days ago

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

    Job DescriptionDaiichi Sankyo, Inc. is a leading pharmaceutical company dedicated to creating innovative therapies for patients worldwide.About the Role:We are seeking an experienced Regulatory Affairs Labeling Expert to join our Global Regulatory Team as a key leader in product labeling and compliance.About You:The ideal candidate will have a strong...

  • Chief Counsel for Health Affairs

    4 weeks ago

    Atlanta, Georgia, United States ACC - Association of Corporate Counsel Full time

    Emory University, a leading academic health system, seeks a seasoned healthcare attorney to serve as Chief Counsel for Health Affairs. As the primary legal advisor to Emory Healthcare's CEO and senior management team, you will oversee all legal matters for the organization's 11 hospitals and over 490 outpatient provider locations.About Emory...

  • Product Regulatory Compliance Manager

    5 days ago

    Atlanta, Georgia, United States Kemira Full time

    About the Job: As a Product Regulatory Compliance Manager, you will play a crucial role in ensuring that our products comply with all relevant regulations and standards. You will work closely with our regulatory affairs team to develop and implement product stewardship programs, maintain regulatory documentation, and liaison with regulatory agencies.Key...

  • Public Health Policy Analyst II

    4 weeks ago

    Atlanta, Georgia, United States ASRT Full time

    About ASRT, Inc.ASRT, Inc. is a leading provider of scientific, information management, management consulting, bioinformatics, and administrative program support services to the Centers for Disease Control and Prevention (CDC) and other Federal and private sector clients. Our team of experts works closely with our clients to identify solutions to complex...

  • Regulatory Affairs Specialist

    4 weeks ago

    Atlanta, Georgia, United States CorDx Full time

    Job OverviewThe Regulatory Coordinator will play a pivotal role in ensuring compliance with regulatory requirements, fostering a culture of excellence at CorDx.

  • Regulatory Affairs Director

    6 days ago

    Atlanta, Georgia, United States InsideHigherEd Full time

    Job Description: Director of ComplianceWe are seeking an experienced professional to lead our compliance program and ensure adherence to all applicable federal and state regulations, accreditation standards, and internal policies.Key ResponsibilitiesDevelop and maintain a comprehensive compliance program, including regular internal audits and risk...

  • Regulatory Affairs Director

    6 days ago

    Atlanta, Georgia, United States InsideHigherEd Full time

    OverviewGenesis Career Group is a leading provider of career-oriented education with 11 campuses across the United States. We are committed to delivering high-quality educational programs that meet the needs of our students and stakeholders. As a key member of our senior leadership team, the Director of Compliance will play a vital role in ensuring our...

  • Governmental Affairs Specialist

    4 days ago

    Atlanta, Georgia, United States League of Southeastern Credit Unions Full time

    At the League of Southeastern Credit Unions, we are seeking a skilled Governmental Affairs Specialist to join our Advocacy Team. This role will be responsible for leading our efforts in Georgia, conducting research and analysis, managing lobbying activities in the Georgia Legislature, and assisting with lobbying for the Georgia Congressional delegation as...

  • Global Regulatory Affairs Expert: Strategic Leadership for Pharmaceutical Labeling

    4 weeks ago

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

    Job Description:This position serves as a GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). The successful candidate will be responsible for managing multiple assigned projects of increased complexity, including...