Abbott Regulatory Affairs Specialist II in Plymouth, 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.
Manage international regulatory submissions to ensure timely regulatory approval of medical devices, with a primary focus on Abbott Electrophysiology (EP) product lines.
Ensure Abbott products and procedures comply with applicable regulatory agency requirements and guidelines.
Monitor changing regulations in international geographies and translate/communicate these requirements to Abbott product development and continuous improvement project teams.
Work with cross-functional teams to prepare and execute regulatory strategy, change management and product release activities.
Manage multiple concurrent projects and deadlines
Performs other related duties and responsibilities, on occasion, as assigned
Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
Bachelor’s degree with a minimum of 2 to 4 years experience working in the medical device or similar regulated industry preferred
Ability to schedule and organize multiple projects
Ability to communicate effectively with internal and external customers and team members.
Requires ability to be innovative, resourceful, and work with minimal direction
Requires excellent organization, problem solving, and communication skills and the ability to work effectively with cross-functional teams
Ability to work in a highly matrixed and geographically diverse business environment.
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.
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
Multitasks, prioritizes and meets deadlines in timely manner.
Strong organizational and follow-up skills, as well as attention to detail.
Ability to travel up to 20%, including international travel.
Ability to maintain regular and predictable attendance.
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 firstname.lastname@example.org