Regulatory Affairs Specialist II

Company: Abbott Laboratories
Location: Saint Paul
Posted on: November 22, 2021

Job Description:

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.Regulatory Affairs Specialist II - St. Paul, MN ABOUT ABBOTT Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of STRUCTURAL HEART disease. We aim to lead the markets we serve by requiring the solutions we offer customers provide an improved benefit/risk profile as compared to existing standards of care; a performance threshold that by definition, guides and ensures the productive output of our engineering, business development, and clinical research efforts result in outcomes that advance the standard of care. WHAT YOU'LL DO We are recruiting for a Regulatory Affairs Specialist II to join our team in the St. Paul, MN location. In this role, you will participate in the day to day operations of the department and be responsible for preparing and managing technical files and regulatory submissions for implantable Structural Heart devices in compliance with medical device regulations in the US, EU (MDD/MDR) and other parts of the world. Responsibilities:

• Perform as regulatory representative on core product development teams and communicate regulatory requirements and impact of regulations to the development teams. Provide regulatory guidance and expertise.
• 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.
• 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.
• Complies with international regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. EDUCATION AND EXPERIENCE YOU'LL BRING Required
  • Bachelor's Degree in Science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), Math, Engineering, or a related discipline
  • 2+ years of medical device experience performing similar responsibilities, including regulatory submissions and/or technical writing.
  • Demonstrated experience reviewing and analyzing documentation
  • Proficient with M/Soft suite (Word, Excel, Outlook)
  • Strong written and verbal communication skill with the ability to effectively communication with all levels of an organization Preferred
    • Advanced level degree
    • Previous experience with PMA's and/or 510ks 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: 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 , on Facebook at and on

Keywords: Abbott Laboratories, St. Paul , Regulatory Affairs Specialist II, Other , Saint Paul, Minnesota