Senior Regulatory Affairs Specialist

18 hours ago

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

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 Mission

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 seeking a Senior Regulatory Affairs Specialist to join our team on-site in St. Paul, MN. This new team member will provide support for the regulatory department to ensure efficient and compliant business processes and environment.

Key Responsibilities
  • Assist in SOP development and review
  • Provide regulatory input to product lifecycle planning
  • Continue to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions
  • Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes
Requirements
  • Bachelor's Degree or an equivalent combination of education and experience
  • 3-4 years' experience in a regulated industry (e.g., medical products, nutritionals)
  • Effective communication, preparation, and negotiation skills
  • Ability to work in a highly matrixed and geographically diverse environment
Preferred Qualifications
  • Master's Degree in Regulatory Affairs preferred and may be used in lieu of direct regulatory experience
  • 5+ years' experience in Medical Device industry
  • 3-5 years of regulatory experience
  • Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society)
About the Role

This role will provide support for the regulatory department to ensure efficient and compliant business processes and environment. The individual will execute tasks and play a consultative role by partnering across business functions as well as assist in identifying data needed, obtaining this data, and ensuring that they are effectively presented for the registration of products worldwide.

What You'll Work On

Assist in SOP development and review. Provide regulatory input to product lifecycle planning. Continue to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions. Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes.

Why Abbott?

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self, and live a full life. We offer a range of benefits, including career development, free medical coverage, an excellent retirement savings plan, tuition reimbursement, and more.

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