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Senior Regulatory Affairs Specialist job in Atlanta at Abbott Laboratories

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Senior Regulatory Affairs Specialist at Abbott Laboratories

Senior Regulatory Affairs Specialist

Abbott Laboratories Atlanta, GA Full Time
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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 109,000 colleagues serve people in more than 160 countries.

ABOUT ABBOTT

Leading an active lifestyle is important to the many people we serve. In Abbott’s ELECTROPHYSIOLOGY & HEART FAILURE division, we’re advancing the treatment of heart and vascular disease through breakthrough medical technologies in EP/HF, allowing people to restore their health and get on with their lives. 

WHAT YOU’LL DO

As a Senior Regulatory Affairs Specialist in Atlanta, you will prepare and manage technical files and regulatory submissions for implantable devices in compliance with medical device regulations in the US, EU (MDD/MDR) and other parts of the world.

Main Responsibilities

  • Provide regulatory guidance and expertise. Perform as regulatory representative on core product development teams and communicate regulatory requirements and impact of regulations to the development teams. 
  • Prepare robust regulatory applications or technical file documentation to achieve departmental and organizational objectives and supports EU MDR transition activities.
  • Identify the need for bench, animal, biocompatibility and clinical data necessary to obtain regulatory approvals with emphasis on US, European CE mark under MDR, Japan, China, Canada and Australia.
  • Review change orders and assesses worldwide regulatory impact of manufacturing or product changes. Review and approve labeling changes to ensure compliance with regulatory requirements.
  • Review technical documentation in order to comply with regulatory/MDR requirements. Prepare and maintain technical files and design dossiers in compliance with MDR. Additionally, may prepare and submit US PMA supplements.
  • Interface directly with regulatory agencies and notified bodies (primarily in the US and EU).
  • Support the product release process by reviewing and approving requests for product release.
  • Develop and maintain Regulatory Affairs procedures.
  • Provide mentoring and leadership to Regulatory Specialist I and II team members
  • Support Department and Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.

EDUCATION AND EXPERIENCE YOU’LL BRING 

Required: 

  • Bachelor’s degree in a technical discipline (i.e. in any of the sciences)
  • 4+ years of regulatory experience from the medical device and/or In Vitro Diagnostic (IVD) industry, including knowledge of regulatory requirements for medical devices in the U.S.s and EU, Quality Systems, and/or ISO Standards
  • Experience with 510(k) applications, PMA supplements and U.S. device regulations and experience with EU and other international medical device regulations and submissions
  • Strong verbal and written communication skills with the ability to listen, articulate and advocate effectively to diverse audiences and at multiple levels in the organization
  • Ability to identify and solve problems and work independently with little oversight
  • Proficient with MS Office (Word, Excel, Outlook)

Preferred: 

  • Advance level degree in a technical discipline (i.e. in any of the sciences)
  • Experience with regulatory submissions for implantable devices

WHAT WE OFFER  

At Abbott, you can have a good job that can grow into a great career. We offer: 

  • Training and career development, with onboarding programs for new employees and tuition assistance  
  • Financial security through competitive compensation, incentives and retirement plans  
  • Health care and well-being programs including medical, dental, vision, wellness and occupational health programs 
  • Paid time off  
  • 401(k) retirement savings with a generous company match 
  • The stability of a company with a record of strong financial performance and history of being actively involved in local communities 

Learn more about our benefits that add real value to your life to help you live fully:  [ Link removed ] - Click here to apply to Senior Regulatory Affairs Specialist  

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity. 

Connect with us at [ Link removed ] - Click here to apply to Senior Regulatory Affairs Specialist, on Facebook at [ Link removed ] - Click here to apply to Senior Regulatory Affairs Specialist and on Twitter @AbbottNews and @AbbottGlobal

 

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