Regulatory Affairs Specialist II

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 109,000 colleagues serve people in more than 160 countries. JOB DESCRIPTION:Leading an active lifestyle is important to the many people we serve. In Abbott's Electrophysiology and Heart Failure division, we're advancing the treatment of heart and vascular disease through breakthrough medical technologies in electrophysiology and heart failure, allowing people to restore their health and get on with their lives.Our location in Plymouth, MN, currently has an opportunity for a Regulatory Affairs Specialist II . In this role, you will be working on specialized level assignments and/or analyses, evaluation, preparation, and submissions for regulatory approval. This role ensures products and procedures comply with regulatory agency requirements. You will also be supporting all necessary regulatory activities required for product market entry and continuation.WHAT YOU'LL DOPrepares robust international regulatory submissions to achieve departmental and organizational objectives.Supports project teams by providing review and analysis of applicable regulatory guidelines and project regulatory assessments as needed.Reviews and evaluates communications to ensure communications convey all necessary detail and adhere to applicable regulatory standards.Maintains current on pertinent domestic and international medical device regulations to ensure submission requirements are current, up-to-date and are entered into regulatory submission database and file systems. Ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel.Collaborates with regulatory affairs peers to ensure successful world-wide regulatory assessments and submissions.Supports the product release process by creating GTS licenses or reviewing and approving requests for product release.Reviewsprotocols and reports to support regulatory submissions.Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.Complies with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.Leads international regulatory projects, ensuring coordination between the regulatory team and impacted business functions.Manages multiple regulatory submission activities in parallel, and balances priorities to align with business objectives.Works with international regulatory colleagues to develop and implement effective regulatory strategies to support timely international approvals, aligned with business objectives.EDUCATION AND EXPERIENCE YOU'LL BRINGRequiredBachelor's Degree in a scientific or technical field or related discipline2+years of like regulatory experience in a R, quality, software, or related environmentStrong verbal and written communications with ability to effectively communicate at multiple levels in the organizationWorked in a highly matrixed and geographically diverse business environmentAbility to identify and solve problems and work independently with little oversightPreferredMaster's Degree in Regulatory AffairsMedical device experiencePrevious experience supporting international regulatory affairsPrior experience working in a broader enterprise/cross-division business unit modelWHAT WE OFFER At Abbott, you can have a good job that can grow into a great career. We offer:Training and career development, with onboarding programs for new employees and tuition assistanceFinancial security through competitive compensation, incentives and retirement plansHealth care and well-being programs including medical, dental, vision, wellness and occupational health programsPaid time off401(k) retirement savings with a generous company matchThe stability of a company with a record of strong financial performance and history of being actively involved in local communitiesLearn more about our benefits that add real value to your life to help you live fully: your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.Connect with us at , on Facebook at and on FAMILY:Regulatory Operations DIVISION:EPHF Electrophysiology & Heart Failure LOCATION:United States > Minnesota > Plymouth : 5050 Nathan Lane N ADDITIONAL LOCATIONS:WORK SHIFT:Standard TRAVEL:Yes, 10 % of the Time MEDICAL SURVEILLANCE:No SIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday) Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law link - English: EEO is the Law link - Espanol: