Regulatory Affairs Specialist

2 days ago

Saint Paul, Minnesota, United States Abbott Laboratories Full time
About Abbott Laboratories

Abbott 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 future, anticipating changes in medical science and technology. Our 114,000 colleagues serve people in more than 160 countries.

Working at Abbott Laboratories

At Abbott Laboratories, 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) 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 getting 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 in the world 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.
Structural Heart Business Mission: why we exist

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.

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.

Key Responsibilities
  • 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.
Requirements
  • 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).

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