ABBOTT LABORATORIES Specialist II, Regulatory Affairs Salary in the United States

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.

This position performs specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for the worldwide regulatory registration, ensuring products and procedures comply with regulatory agency specifications.  Supports necessary regulatory activities required for product market entry

• Prepares robust regulatory applications (either for FDA, and/or for international regulatory agencies) to achieve departmental and organizational objectives.
• Conducts reviews of product and manufacturing changes for compliance with applicable regulations.
• Acts as a regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to the development team.  Provides guidance and expertise.
• 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.   
• May interface directly with FDA and other regulatory agencies.
• Work with cross-functional team to support product release process.
• 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.
• Performs other related duties and responsibilities, on occasion, as assigned

Qualification:

• BA or BS degree; technical discipline preferred.
• Minimum 3 years of experience, including a minimum of two years regulatory experience.
• Experience writing with PMA and 510(k) applications.
• Experience working with US device regulations and with EU and other international medical device regulations and submissions.
• Experience working on project teams (new product development and/or sustaining)
• Experience working with software as medical device and Class III is a plus.
• Experience working in a broader enterprise/cross-division business unit model preferred.
• 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 approximately 10%, including internationally.
• Ability to maintain regular and predictable attendance.