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 recruiting for a Regulatory Affairs Specialist II to join our team in the St. Paul, MN location. 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.
Prepares robust regulatory submissions for the US and EU to achieve departmental and organizational objectives.
Creates, reviews and approves engineering changes.
Acts as core team member 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 including those set by the FDA or other worldwide regulatory agencies to various international affiliates.
Maintains current on pertinent domestic and international medical device regulations to ensure submission requirements for US and EU are current, up-to-date and are entered into regulatory submission data base 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 international regulatory affairs peers to ensure successful world-wide regulatory assessments and submissions.
May interface directly with FDA, EU Notified Bodies, and other regulatory agencies.
Supports the product release process by creating GTS licenses or reviewing and approving requests for product release.
Reviews protocols 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.
Bachelor's Degree in a scientific or technical field or related discipline
2+ years of like regulatory experience in a R&D, quality, software, or related environment
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
Worked in a highly matrixed and geographically diverse business environment
Ability to identify and solve problems and work independently with little oversight
Experience with US and/or EU medical device regulations
Master's Degree in Regulatory Affairs
Medical device experience
Experience with either 510(k) applications and/or PMA supplements
Prior experience working in a broader enterprise/cross-division business unit model
EPHF Electrophysiology & Heart Failure
United States > Minnesota > St. Paul > Lillehei : One Lillehei Plaza
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
EEO is the Law link