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.
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.
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
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
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 email@example.com