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Abbott Senior Regulatory Affairs Specialist in St. Paul, Minnesota

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 103,000 colleagues serve people in more than 160 countries.

Position Summary:

We are currently recruiting for a Senior Regulatory Affairs Specialist to join our team in the St. Paul, MN location. In this role, you be responsible for coordinating, planning, preparation, assembly, and review of regulatory submissions to the FDA and other worldwide regulatory agencies.

Primary Responsibilities:

  • Acts as a regulatory representative on core product development teams developing and communicating regulatory strategy, requirements, and impact of regulations

  • Review and approve all design control documentation (i.e. protocols, reports, labeling, etc.) required to support regulatory submissions

  • Maintains positive and cooperative communications and collaboration with all levels of colleagues, customers, contractors, and vendors

  • Review and approve product and manufacturing changes through the engineering change order process to assure compliance with regulatory requirements

  • Acts as liaison between Abbott and the various appropriate regulatory agencies

  • Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements

  • Provides mentoring and leadership to team members

  • Performs other related duties and responsibilities, on occasion, as assigned

Required Qualifications:

  • Bachelor’s Degree

  • 4+ years in a technical role, including at least 3 years of experience in the medical device industry

  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization

  • Ability to identify and solve problems and work independently with little oversight

  • Experience with US and/or EU medical device regulations

Preferred Qualifications:

  • Degree in a technical discipline (i.e. in any of the Sciences)

  • Experience working in a cross-division business unit model preferred

  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment

  • Ability to leverage and/or engage others to accomplish projects

  • Multitasks, prioritizes and meets deadlines in timely manner

  • Strong organizational and follow-up skills, as well as attention to detail

  • Ability to travel approximately 5%, including internationally

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com

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