Regulatory Affairs Rotational Program

Job description

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.

JOB DESCRIPTION:

This position is included in the Regulatory Affairs Rotational Program (RARP) and performs multiple rotations that include specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for regulatory registration, ensuring products and procedures comply with regulatory agency specifications. 

Supports necessary regulatory activities required for product market entry. 

Additionally, during certain rotational periods the position may be responsible for regulatory operations activities such as logistics management of global product release, and maintaining tools needed for managing global regulatory business such as the regulatory database and global regulatory SharePoint sites. 

Job Duties:

• Assists in the preparation of regulatory applications (including annual reports) to achieve departmental and organizational objectives.
• Creates, reviews and approves engineering changes.
• Acts as a regulatory representative responsible for review and analysis of applicable regulatory guidelines.
• 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 pertinent domestic and international medical device regulations to ensure submission requirements world-wide 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, if requested.   
• Supports the product release process by creating GTS licenses or reviewing and approving requests for product release.
• May interface directly with FDA and other regulatory agencies if so directed.
• 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) regulations, international regulations and 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.
• Performs other related duties and responsibilities, on occasion, as assigned.
• Opportunity for someone highly interested in long term RA career to grow at a multifunctional, multi divisional company.

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